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Serialisation, Artwork Management and Supply Chain Strategy
for Pharma, Biotech and Medical Devices Industries

Executive Briefing

Avoiding the supply risk from
serialisation with CMOs

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DSCSA & EU FMD now live

Speak 1:1 with a Serialisation Expert for free

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MAKING PHARMA 2019

Be4ward’s expert speakers at Making
Pharma Conference 2019

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BE4WARD AWARD WINNING

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Artwork Error - A significant recall risk

Is your process world class?

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and white papers

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Training Course: Packaging Artwork Document Verification and Proofreading

This course helps professionals involved in the checking, proofreading or approval of packaging labelling and artwork documents to ensure that they eliminate errors critical to patient safety.

EXCLUSIVE STUDY GROUP

Educational research has shown that students who can work together during training are much more likely to complete a course successfully. Therefore, in addition to the above, you will get membership of an exclusive discussion group where you can get help from and share experience with other students on the course.

Selective focus on the word "proofreader". Many more word photos in my portfolio...

Course Structure

Each module provides you with:

  • Audiovisual lectures from an expert
  • Self study materials
  • A test to ensure you have understood the critical elements of the module

At the end of the course, you will receive a certificate you can add to your training record.

Course Contents

  1. Introduction

  2. The Content of a Packaging Artwork

  3. Why Proofreading is Important and How Mistakes Are Made

  4. Manual Text Checking

  5. Electronic Text Comparison

  6. Manual Graphical Checking

  7. Electronic Graphical Comparison

  8. Technical Check

  9. Workplace

  10. Competence and Ongoing Learning

  11. Close

 We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Serialisation Publishing

Responding To Serialisation Legislation

Pharmaceutical product serialisation legislation is being developed and approved across the World to help ensure patient safety and prevent reimbursement fraud. Achieveing this across the supply chain is a major and very costly undertaking. Failure to comply with the legislation will mean that companies cannot sell products in the affected markets. This White Paper explains this legislation, its impacts and describes how pharmaceutical companies should tackle the legislation in the most effective way.

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Top 13 of Things To Do Before Starting a Serialisation Project

While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded many lessons learnt and continues to do so. This booklet explains some of the key things that we wish we had known before embarking on our early projects.

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Top 10 Tips for Developing a Serialisation Strategy

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company such as Regulatory and legislative management and government affairs, Packaging operations, Distribution operations and IT. These capabilities must be implemented effectively in a timely manner to ensure product supply is maintained. The following is a series of tips for developing and implementing your serialisation strategy.

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Artwork Management Publishing

Top 20 Artwork Auditor Tips

We list the top 20 things to consider when auditing pharmaceutical packaging labelling and artwork content creation capabilities. The booklet is designed to help auditing professionals improve their auditing techniques.If you would like a hard copy of this booklet, please send us an email.

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Reducing Packaging Recall Risk

Packaging artwork is a complex but often overlooked aspect in the design of pharmaceutical products. Unfortunately, packaging artwork errors are one of the main causes of product recalls. Many factors are driving companies to increase their product range. This brings with it a corresponding increase in the risk of artwork related recalls and near misses. In this white paper, we draw on our extensive experience of designing, implementing and managing global packaging artwork capabilities to help you understand how to minimise these risks.

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Top 15 Causes of Proofreading Errors

Proofreading is a critical quality control step in the process of ensuring that the packaging labelling and artwork of finished pharmaceutical product is correct. Mistakes in this artwork can put patient safety at risk. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential to patient safety. This booklet identifies a number of errors which are typically seen in the design and execution of proofreading capabilities which should be avoided to ensure a quality proofreading result.

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Ensuring effective translation

As globalisation increases and companies reach customers in many more markets around the world, the need for accurate and comprehensive translations increases. Translation activity is an often forgotten back-room process. It is rarely considered core to a company's operations, but failure in the process results in incorrect information being provided to customers, suppliers, regulators or shareholders. At minimum this is embarrassing and may not show the company in the best light. However some errors can be significant, impacting the safety of the customer or agreements with regulators. These can seriously damage the company's reputation and lead to sanctions and fines. This booklet provides a series of tips to help you establish your translation capability based around a 10 step process.

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Supply Chain Packaging Publishing

Top 20 Packaging Complexity

Stock Keeping unit (SKU) and packaging component portfolio control is a critical activity for organisations. Ensuring the correct balance between a commercially advantageous portfolio, whilst minimising unnecessary pack and component variants is a challenge faced by many healthcare product companies as they grow their product range and expand into new markets. Therefore ensuring there are decision making processes in the organisation to manage required levels of complexity is a key aspect of effective pack management. This booklet takes the popular Top 20 Tips format to describe key features of a complexity management capability in an easy to digest format.

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Legal Entity Publishing

Managing Product Licence and Packaging Changes Post Merger or Acquisition

We draw on our team's award winning experience in the management of product licence and packaging changes in the aftermath of mergers and acquisitions to explain how to achieve this complex task whilst minimising supply risk and cost.

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OUR EXPERTS BLOGS

Andrew and Stephen share their views and tips on their respective blogs with regular posts on all the topics related to Serialisation, Artwork, Proofreading, Packaging Supply Chain Optimization.

Visit their respective blog often and share their posts with your teams.

Andrew Love
Vice-President

See Andrew's particular take on Artwork Management, Translation and Proofreading Practices.

See Andrew's Blog
Stephen McIndoe
Vice-President

See Stephen tips and take on Serialisation and Packaging Supply Chain Optimization Practices.

See Stephen's Blog
CONSULTING SERVICES
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Products Serialisation
Whether you are already on your serialisation journey, or just embarking on it, Be4ward has a broad range of consulting services to help your Serialisation Program/Projects/Operations be successful.

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EU FMD

medicine

Packaging Supply Chain Optimization
Be4ward has helped a number of clients to optimize their product portfolio and packaging range. They also designed optimal packaging supply chains to deliver high degrees of customer service for small order quantities.

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medicine

EU MEDICAL DEVICE REGULATION
The requirements for the new legislation impact the majority of parties involved in the supply and governance of medical devices to the EU market across the entire lifecycle of each device. Be4ward can help you understand and implement solutions.

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artwork

Labelling and Artwork Management
Packaging labelling and artwork present a significant compliance risk. Be4ward helps companies to get world class capabilities to mitigate this risk and reduce their level of recalls.

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Legal Entity and Brand Integration
Be4ward has a proven approach tool kit and experienced consultants to help companies successfully manage their legal entity  and brand integration projects.

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We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download Your On-Demand Webinar

Graphic for Publishing page On-Demand Webinar Do It Right The First Time- Reduce Compliance Risk and Streamline your Labeling and Artwork Processes

Do It Right The First Time: Reduce Compliance Risk and Streamline your Labeling and Artwork Processes into World-Class Capabilities

We all understand that packaging and artwork still present a significant compliance risk and delivering right first time artwork is a complex endeavor involving many moving parts. Furthermore, being right first time increases speed, reduces waste and raises confidence. Hear from a leading expert on how to increase patient safety, improve regulatory compliance and increase sales by providing error-free artwork and a streamlined Labeling process. Andrew Love will provide clear direction on how you can establish world-class labeling and artwork capabilities.

Please provide your name and email address for your free download.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

EU FMD Strategy front cover image

10 Tips to Accelerate your EU Falsified Medicines Directive (FMD) Strategy

The countdown is well under way, with significantly less than two years until the EU Falsified Medicines Directive (EU FMD) serialisation compliance deadline – will your company be ready in time? With 32 countries across Europe being affected by this legislation, in this booklet we will discuss 10 tips to consider whilst developing and implementing your EU FMD serialisation strategy. Avoid supply interruption, make sure you have robust, realistic plans to address February 2019 EU FMD requirements.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Graphic of front cover Introduction to MDR booklet

An Introduction to the EU Medical Device Regulation (EU MDR)

Billed as the most significant changes to medical device legislation in decades, these regulations seek to increase the safety and effectiveness of medical devices available in the EU market and address weaknesses in the regulations revealed in several high profile incidents. Medical device and in vitro diagnostic device manufacturers large and small who supply product to the EU market will be impacted and need to start planning now on how to transition to the new requirements.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your On-Demand Webinar
On-demand EU FMD webinar graphic

EU Falsified Medicines Directive: How to Develop a Comprehensive Plan with Rapid Implementation

The countdown to EU Falsified Medicines Directive (EU FMD) compliance is underway. With fewer than two years until the serialisation compliance deadline takes effect, industry serialisation leaders, Optel Group, Be4ward and Verify Brand, present a free 60-minute webinar for pharmaceutical organisations that must comply with EU FMD. The webinar, “How to Develop a Robust Plan with Rapid Implementation,” provides pharmaceutical companies with the tools to develop a comprehensive strategy and implementation plan in advance of the February 9, 2019 EU FMD compliance deadline.

 With 32 countries across Europe being affected by the EU FMD legislation, this webinar will help pharma companies avoid supply interruption, identify key solutions tailored specifically for rapid implementation, and implement EU FMD solutions with minimal impact to organisational resources.

 The webinar presenters are all experts in the field of serialisation: Jean-Pierre Allard, Chief Technology Officer at Optel Group; Stephen McIndoe, Be4ward Serialisation Practice Vice President; and Dhermita Desai, Verify Brand Senior Project Manager. Webinar topics include:

 an overview of the EU FMD legislation -- where we are now, the implications of EU FMD on an organization, and complex implementation scenarios pharma organizations may encounter;

  • the key elements of successful EU FMD planning and execution;
  • how to make sure that your packaging meets EU FMD product tamper evidence requirements;
  • how to ensure that your serialisation software seamlessly connects to your trading partners and delivers all your EU FMD requirements (e.g., configuration, validation, initial and ongoing support).

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Top 10 RFT tips to streamline and imprve your artwork process image

Top 10 Right‑First‑Time Tips to Streamline and Improve Your Artwork Process

We all understand that packaging and artwork still present a significant compliance risk and delivering right‑first‑time artwork is a complex endeavour involving many moving parts. Furthermore, being right‑first‑time increases speed, reduces waste and raises confidence. From this booklet, we can see that achieving high right‑first‑time is doable, but there are many parts to be addressed, requiring focus and persistence. As such, right‑first‑time is as much a mindset as an outcome.

BE-EDUCATED: LABELLING AND ARTWORK EDUCATION FOR THE WHOLE TEAM

Labelling and artwork education is critical to ensure that all members of your team can contribute efficiently and effectively to your labelling and artwork activities.

From senior steering team members to artwork operators, they all need to receive the appropriate labelling and artwork education to contribute effectively and make the myriad of decisions they need to as part of their role.

Be4ward offers a number of educational products to assist you in ensuring that your team members have the appropriate level of knowledge to contribute effectively to your labelling and artwork activities, including:

  • Labelling and artwork education workshops
  • Labelling and artwork education webinars
  • Labelling and artwork team member education coaching
  • Bespoke education events and materials development

Don't hesitate to contact us to discuss your needs.

BE-RESOURCED

Labelling and artwork is a very cross-functional and cross-organisational topic. Improvement programmes need numerous skills – Functional SMEs, technical and technological skills, change management skills, programme and project management skills.

Be4ward has access to a broad range of suitably skilled and experienced team members and can provide these people to clients either on a full or part time basis. The types of people we typically provide to clients include:

  • Senior subject matter experts
  • IT architects
  • Business analysts
  • Change management consultants
  • Validation specialists
  • Program and project managers

If you are struggling to design your team or staff, please do not hesitate to contact us and discuss how we might help.

BE-GOVERNED: ESTABLISHING EFFECTIVE LABELLING AND ARTWORK GOVERNANCE

For any labelling and artwork program to be successful, governance needs to be put in place across all the parties involved to ensure that decisions are made, and activity is coordinated, in a manner that will lead to timely implementation of the end-to-end solutions. In the lack of such governance, it is all too easy for local teams to make their own interpretations of requirements, define solutions and timelines in isolation, resulting in the end-to-end solution that does not work.

Be4ward has extensive experience establishing and supporting labelling and artwork steering and governance teams, including such aspects as:

  • Designing governance/steering teams
  • Coaching and preparing for meetings
  • Facilitating significant decision making
  • Managing senior stakeholders
  • Facilitating meetings

BE-OPERATIONAL: ESTABLISHING EFFECTIVE ONGOING OPERATIONS AND SUPPORT

As a labelling and artwork program progresses through initial implementations, the need to operationalise the new capabilities will become necessary. The implementation of new systems will require user and system support that may not have been necessary in the past.  Some aspects of these new labelling and artwork capabilities may be absorbed into existing organisation responsibilities. However, there will often be some new or significantly enhanced support capabilities to be put in place.

If this requirement is not dealt with early in the life of a labelling and artwork program, there is a significant risk that the program and project teams will be pulled away from their new capability implementation activity to deal with operational troubleshooting. Whilst solving the immediate operational needs, this will inevitably result in risk to the delivery of the remainder of the program.

Be4ward has experience in helping clients define and design support capabilities that address the particular cross-functional and often cross-organisation issues associated with end-to-end labelling and artwork solutions.

Improvements to the labelling and artwork service in many organisations requires running a program of projects to put a variety of different capabilities in place. Be4ward works with many organisations to help deliver all aspects of this implementation activity.

BE-DESIGNED

Designing the most appropriate solutions, be they labelling and artwork processes, organisations, technologies or capabilities that are required for an effective end-to-end labelling and artwork solution is at the core of what the Be4ward team of labelling and artwork subject matter experts do.

We have experience in designing the most appropriate solutions for our clients no matter how large or small their organisation is, however complex or straight forward it may be. We are also very used to dealing with virtual organisations, where many of the capabilities that are required will need to be delivered through third party organisations such as external artwork and graphics providers, translation providers, contract manufacturers and printed component suppliers.

The end result of much of the design process is a set of design documents. Through our extensive experience, our team has developed a number of tools that help us ensure that we can help clients author comprehensive design documentation in a timely and efficient manner.

Be4ward prides itself on its independence from the supply base. This allows us to help clients make the impartial decisions that are critical to their success.

BE-SELECTIVE: SELECTING THE APPROPRIATE SUPPLIERS

Implementing labelling and artwork capabilities involves selecting a number of different vendors to provide different aspects of the end-to-end solution.  Some of these are significant purchases and others are long term service relationships.  For many organisations these sourcing decisions require a significant amount of rigor to ensure that the most appropriate providers are selected.

To complicate matters further, the supply base for labelling and artwork solutions and service providers are broad, with many different suppliers who have varying levels of capability. Be4ward's experience in selecting and working with many vendors can provide clients with critical insights that they would otherwise not have had access to in the procurement process.

Be4ward is often employed by clients to assist in the overall procurement process. Indeed, we can run the entire procurement process if necessary. Our involvement often includes such aspects as:

  • Authoring requirements documents
  • Authoring procurement process documents
  • Analysing vendor responses and responding to their questions
  • Running and/or participating in vendor interview/demonstrations
  • Summarising and presenting recommendations to senior management

BE-PLANNED: DEVELOPING LABELLING AND ARTWORK PROGRAM AND PROJECT PLANS

Labelling and artwork is no different to any other complex, multi-disciplined, multi-organisation program, it needs a bespoke set of plans to ensure optimal delivery in any particular situation. Furthermore, these plans need to be designed to be adaptable to the inevitable challenges and changes that will occur.

Having been involved in many labelling and artwork programs and in various roles, we have the experience in developing and executing labelling and artwork program and project plans.

When planning labelling and artwork activities, our clients gain access to a wealth of planning knowledge that has been tried and tested.

BE-ORGANISED: PUTTING IN PLACE THE APPROPRIATELY SKILLED TEAMS

Labelling and artwork is a very cross-functional and cross-organisational topic. Improvement programmes need numerous skills – Functional SMEs, technical and technological skills, change management skills, programme and project management skills.

One of the initial challenges an organisation faces when embarking on a labelling and artwork improvement programme is to understand what roles they will need to support their program. Be4ward can assist in helping design appropriate teams, define role specifications and assist in the selection process.

Furthermore, Be4ward has access to a broad range of suitably skilled and experienced team members and can provide these people to clients either on a full or part time basis. The types of people we typically provide to clients include:

  • Senior subject matter experts
  • IT architects
  • Business analysts
  • Change management consultants
  • Validation specialists
  • Program and project managers

If you are struggling to design your team or staff, please do not hesitate to contact us and discuss how we might help.

BE-VALIDATED: ENSURING SOLUTIONS ARE APPROPRIATELY VALIDATED OR TESTED

Labelling and artwork systems deal with critical GMP data and handle information impacting patient safety.  Furthermore, in most cases companies are looking for electronic signature functionality to avoid paper approval of artworks.  This drives a requirement for the highest standards of system validation.

For the majority of companies, applying the appropriate quality standards and processes to a program and their resulting capabilities is critical to success.

Our team has worked with many clients to help define and implement the appropriate approaches to the quality and validation aspects of labelling and artwork system functionality.

BE-FINANCED: DEVELOPING LABELLING AND ARTWORK PROGRAM AND PROJECT FINANCIAL ESTIMATES

Financial estimates are critical in many organisations to secure the appropriate finance to implement new capabilities.

Labelling and artwork is very cross functional and involvement in budgeting from all of the functional areas involved is essential to develop reliable estimates.  This can be difficult to do without the benefit of experience.

The Be4ward team has the experience of multiple projects that they can use to help companies develop thorough and robust estimates.

BE-STRATEGIC: LABELLING AND ARTWORK STRATEGY DEVELOPMENT

Be4ward's strategy development service brings together a number of our labelling and artwork products to help organisations develop an initial understanding of how to develop your labelling and artwork service. Typically, strategy development would include:

  • Understanding of the current operations against industry best practice
  • Assessing the impact of desired changes on the company’s operations, including any opportunities that might present
  • Initial high level designs of the labelling and artwork service – processes, organisation, technology and capabilities
  • High level roadmap for managing these impacts and the resulting new capabilities that will need to be put in place
  • Cost and resource impact estimation
  • Plan for the next phase of activity

Given the situation that some organisations find themselves in, it may also be appropriate to develop some key documents in parallel with the strategy activity to ensure effective mobilisation of the program. These might include such things as key user requirements specifications and supplier selection documents.

Organisations need to consider how they periodically refresh their labelling and artwork strategy on an ongoing basis. It must not be forgotten that the environment within which labelling and artwork operates changes over time and the strategy must reflect these evolving requirements.

BE-COMPLIANT: ENSURE ROBUST WAYS OF WORKING

  • Labelling and artwork presents a significant compliance risk. This represents one of the largest causes of recalls in the pharmaceutical and medical industry. For many companies, their current capabilities are struggling to meet today’s requirements.

BE-CAPABLE: HAVE THE RIGHT CAPABILITIES TO MEET YOUR COMPANY’S BUSINESS STRATEGY

  • There are important and immediate business challenges facing the pharmaceutical and healthcare industry. Pharmaceutical and other healthcare companies are facing one of the most difficult periods in their history.
  • Delivering many new product variants into as many different markets as quickly as possible is vital for their short and long-term viability. At the same time, they need to enhance their reputation with regulators, governments, the public and other key stakeholders.
  • Packaging artwork management capabilities are critical to delivering this business strategy. Essential to the strategy described above is the need to be able to develop, deliver and maintain a significantly increased number of packaging artwork designs for a rapidly expanding number of markets.
  • For many companies, today’s capabilities will not achieve this without significant improvement.

BE-CROSS FUNCTIONAL: LABELLING AND ARTWORK IMPACTS MANY PARTS OF YOUR BUSINESS

  • Delivering quality labelling and artwork is a complex endeavour involving many moving parts.
  • In the largest organisations, artwork capabilities involve thousands of people, working across many internal functions, in more than one hundred countries, involving tens, if not hundreds of external organisations. The capabilities require the skilful design and management of integrated business processes, organisations and facilities, which are enabled by a suite of sophisticated information technology systems.
  • In smaller companies, whilst the scale is reduced, the fundamental challenges remain unchanged. Establishing and delivering improvements in artwork capabilities is a significant, but achievable change management challenge.
  • Delivering change in this area requires the management of a complex interaction of business processes: people in many different functions, organisations and countries using many, often validated information technology tools.
  • This requires careful and skilled project and change management skills to do it effectively if significant compliance risks are to be avoided.

BE-EXCELLENT: SERVICE EXCELLENCE IS ACHIEVEABLE

  • Excellence is achievable.
  • We have transformed and managed the global artwork operations for one of the world’s largest pharmaceutical companies, creating a world-class capability which has sustained industry leading performance over many years.
  • We continue this journey by offering a range of services to our clients to help them deliver step change improvements in their labelling and artwork capabilities.

Specialised in labelling and artwork, the Be4ward team has been working with the world's largest and smallest Pharmaceutical, Biotech and Medical Devices companies with their CMO's to deliver fit for purpose, robust labelling and artwork solutions.

With Be4ward’s senior consultants having over 25 years of experience each in the industry, Be4ward have helped clients across the lifecycle of labelling and artwork solution implementation:

  • Developing labelling and artwork service strategies
  • Requirement development
  • Independent supplier selection – systems, artwork, translation and print suppliers
  • Detailed design – process, organisation, technology and capabilities
  • Service partner integration design and negotiation
  • Implementation support
  • Validation
  • Support model design and implementation
  • Project and program management

Avoid supply interruption, make sure you have robust, realistic plans to address the new EU MDR legislation

The requirements for the new legislation impact the majority of parties involved in the supply and governance of medical devices to the EU market across the entire lifecycle of each device. It is crucial that your company has a comprehensive, robust and realistic plan in place to define your strategies for transition. If you don’t have such a plan in place, act now – contact Be4ward to understand how we can help deliver your strategy and plan quickly, with minimal impact to your team.

The clock is ticking on the new EU Medical Device and In Vitro Diagnostic Device Regulations. Following approval in March 2017 by the European Council and in April 2017 by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 – were published in the Official Journal of the European Union on 5th May 2017. Both Regulations entered into force on 26 May 2017, hence the new MDR rules will apply from 26 May 2020 and the IVDR rules from 26 May 2022.

Billed as the most significant changes to medical device legislation in decades, these regulations seek to increase the safety and effectiveness of medical devices available in the EU market and address weaknesses in the regulations revealed in several high profile incidents. Medical device and in vitro diagnostic device manufacturers large and small who supply product to the EU market will be impacted and need to start planning now on how to transition to the new requirements.

 

Understand the full impact of the legislation

It is time that you understand the full impact of the legislation and local requirements on your organisation before it is too late, and make sure you are doing the critical path activities you need to be doing now. There are a number of changes being introduced by the new regulations, some of the most significant being:

The role of Economic Operators: Economic Operators (the collective description for Manufacturers, Importers, Distributors, Suppliers, Subcontractors and EU Authorised Representatives) carry the ultimate responsibility for conformity to regulations.  The legislation outlines the general obligations of each or these parties, explaining both what they need to do and how they need to do it.

The scope and Classification of products:  Whilst the classification system (Class III, Class IIa, Class IIb and Class I) is retained, some rules have been tightened. Some industry commentators anticipate this could result in some devices moving to higher classes of product. Moreover, a number of types of products that were previously exempt from the regulations are now included in scope.

Technical files, common specifications, clinical evidence, conformity assessments and product labelling:  Additional requirements have been included to each of these aspects of product registration and approval. These may require further product information or testing to be provided to support approval. Transitioning arrangements for existing products or products currently undergoing conformity assessment are being clarified but some industry experts are concerned that these new requirements could require all products to be registered as they transition to the new legislation.

Vigilance and post-market surveillance: The regulations introduce further requirements for vigilance and post-market surveillance undertaken by both the Economic Operators and the National Authorities.

Quality Management System: All manufacturers and their representatives must have an appropriate quality management system.

Person responsible for Regulatory Compliance: The regulations require that manufacturers and authorised representatives have permanently and at their disposal at least one person responsible for regulatory compliance. This isn’t necessarily an employee, but must be accessible to the organisation. The person is responsible for ensuring the conformity of devices are checked prior to release including that technical documents and certificates of conformity are accurate.

Notified body re-designation: The legislation includes a series of requirements for notified bodies who will be required to be re-designated as part of the regulation. It is targeted to have this complete towards the end of 2018.

Unannounced Audits: Notified bodies will be required to undertake unannounced audits of manufacturers and their authorised representatives. Notified bodies will have to provide schedules of unannounced audits to their National Authorities.

Medical Device Coordination Group: The legislation includes the creation of a pan-EU expert committee, The Medical Device Coordination Group (MDCG). This will comprise representatives from the member states and will assist the Commission in the implementation and operation of the new legislation.

Unique Device Identification (UDI): UDIs will be introduced on all medical devices. They will be placed on the label of the device, implant cards for Class III devices, and in the case of re-useable devices, potentially on the device as well. These UDIs will be used to provide traceability of use of devices.

EUDAMED database: The Commission will establish a centralised EU database for the storage of information on medical devices (EUDAMED). This will facilitate the communication of both pre- and post-approval product information between economic operators, the Commission, member states and in some cases healthcare professionals and the public. It is targeted to have this database available towards the end of 2018.

Be4ward provide independent support

Be4ward has local teams in Europe and North America that can help you and your company understand and implement solutions for the EU MDR legislation. Here are some of the key reasons why you should engage with an independent consultancy like Be4ward:

  • Your company does not have the internal resources and/or capacity to develop internal knowledge and stay up to date with the evolving legislation and local country requirements. Be4ward is helping many clients understand and stay up to date with the legislation and local requirements.
  • You want to understand all your options. Be4ward can help you understand that you have options in how to meet the EU MDR legislation deadlines and help you choose the right solutions for your particular situation.
  • You need help understanding the supply base and selecting appropriate solution provider(s) for your situation. Be4ward have a thorough understanding of the supply base, whilst at the same time being completely independent from it. Therefore, we can help you select the most appropriate solution provider(s) for you.
  • You need experienced subject matter expert support in your implementation phase. Once you get into implementation, you will likely need incremental resources of varying different skills and knowledge at various times to help design, develop and implement EU MDR capabilities. Be4ward can provide you with these crucial resources to help you succeed in your implementation.

How Be4ward can help

Be4ward work with the world's largest and smallest Pharmaceutical, Medical Device and Biotech companies and their CMOs to deliver fit for purpose, robust solutions for global legislations. Here are some of our service offerings that will ensure your company efficiently meets the EU MDR deadlines:

EU MDR Strategy Development

Be4ward's strategy development service brings together a number of our EU MDR products to help organisations develop an initial understanding of how to tackle EU MDR. For more information please contact us at enquiries@be4ward.com to find out more about our EU MDR Strategy Development service and how it can help your company.

Other EU MDR Services

Be4ward provides various EU MDR services that can help your company meet the EU MDR deadlines in a time effective and efficient manner:

EU MDR Strategy, EU MDR legislation

Contact us

Should you have any questions about the EU MDR legislation, please don’t hesitate to contact us at enquiries@be4ward.com for more information.

Organisations Membership

As member of these renowned organisations, we ensure to provide services using the latest standards and good practices related to your business.

 

Avoid supply interruption, make sure you have robust, realistic plans to address Feb 2019 EU FMD requirements

It is crucial that your company has a comprehensive, robust and realistic plan in place to deliver EU FMD serialisation and avoid product supply issues. If you don’t have such a plan in place, act now – contact Be4ward to understand how we can help deliver your strategy and plan quickly, with minimal impact to your team.

EU serialisation requirementsThe countdown is well under way, with significantly less than two years until the EU Falsified Medicines Directive (EU FMD) serialisation compliance deadline – will your company be ready in time? With 32 countries across Europe being affected by this legislation, Be4ward help to ensure you have a robust comprehensive strategy and implementation plan in place before it is too late. Furthermore, following the planning stage, Be4ward has a comprehensive suite of serialisation, program and project management services that can help you deliver your serialisation solutions in an efficient and effective way, minimising supply risk.

If you are currently dealing with the US DSCSA legislation, you will already be aware of the complexities, issues and risks involved in delivering serialisation capabilities, even though the US is only one market with a relatively simple November 2017 requirement. Some companies are waiting to tackle EU FMD until after their US solutions are in place. This is a very high risk strategy for many companies, given the complexities and real lead times of delivering serialisation solutions for Europe.

Don’t let internal issues stop you acting now

Currently dealing with the US DSCSA legislation?

  • Is your team telling you they have no capacity to start planning for EU FMD until after DSCSA is complete?
  • Are you concerned by the number of products and markets in Europe, but your team is telling you that EU FMD is just one piece of legislation, like the US, and therefore it will be simple to implement?
  • Do you have a small number of CMOs and packaging sites you are connected to in the US, but in Europe you have lots more?
  • Are you hearing discussions about the local country requirements in Europe and that there are still a lot of details to be decided?

If you can answer yes to any of these questions, it is time that you understand the full impact of the legislation and local requirements on your organisation before it is too late, and make sure you are doing the critical path activities you need to be doing now.

 

New or inexperienced with serialisation?

  • Is your company new to serialisation, or has only dealt with serialisation locally for the likes of Turkey?
  • Is your team telling you that EU FMD is just one piece of legislation, therefore it will be simple to implement?
  • Are you hearing discussions about the local country requirements in Europe and that there are still a lot of details to be decided?
  • Are you concerned about who is going to pay for the EU national systems access?
  • Are you concerned that you do not have the skills, knowledge or capacity internally to understand the true impact of serialisation on your organisation?

If you can answer yes to any of these questions, it is time that you understand the full impact of the legislation and local requirements on your organisation before it is too late, and make sure you are doing the critical path activities you need to be doing now.

 

Are you a CMO that is unsure of your responsibility and involvement in preparing for the EU FMD legislation for your customers?

  • Are you a CMO that is receiving questions from your customers about how you will tackle EU FMD serialisation for them, but you do not feel fully informed to answer them?
  • Are you frustrated that your customers are not being clear about what they want?
  • Are you concerned about who is going to pay for these new serialisation capabilities?
  • Are you concerned about how to deal with multiple different customer requirements?
  • Are you concerned that you will be asked by your customers to deal directly with the EU hub (EMVS) and national systems (NMVS)?

If you can answer yes to any of these questions, it is time that you understand the full impact of the legislation and local requirements on your organisation before it is too late, and make sure you are doing the critical path activities you need to be doing now.

 

Be4ward provide independent support

Be4ward has local teams in Europe that can help you and your company understand and implement solutions for the EU FMD legislation. Here are some of the key reasons why you should engage with an independent consultancy like Be4ward:

  • Your company does not have the internal resources and/or capacity to develop internal knowledge and stay up to date with the evolving legislation and local country requirements. Be4ward is helping many clients understand and stay up to date with the legislation and local requirements. We are also active members of the GS1 EU FMD implementation team.
  • You do not have the time or budget to make mistakes. Be4ward have learnt through experience of the many issues and risks associated with serialisation through their work with other client’s projects, so you don’t have to.
  • You want to understand all your options. Be4ward can help you understand that you have options in how to meet the EU FMD legislation deadline and help you choose the right solutions for your particular situation.
  • You need help understanding the supply base and selecting appropriate solution provider(s) for your situation. Be4ward have a thorough understanding of the supply base, whilst at the same time being completely independent from it. Therefore, we can help you select the most appropriate solution provider(s) for you.
  • You need experienced subject matter expert support in your implementation phase. Once you get into implementation, you will likely need incremental resources of varying different skills and knowledge at various times to help design, develop and implement serialisation capabilities. Be4ward can provide you with these crucial resources to help you succeed in your implementation.

How Be4ward can help

Be4ward have been working with the world's largest and smallest Pharmaceutical companies and their CMOs to deliver fit for purpose, robust serialisation solutions for EU FMD and other serialisation legislations. Here are some of our service offerings that will ensure your company efficiently meets the EU FMD February 2019 deadline:

Serialisation Strategy Development

Be4ward's strategy development service brings together a number of our serialisation products to help organisations develop an initial understanding of how to tackle serialisation. For more information on this service, click here.

Serialisation Health Check

If you already have a serialisation program in place, our Serialisation Health Check can help you understand any potential issues and gaps you may have over looked and put in place the appropriate corrective measures. Contact us at enquiries@be4ward.com to get more information.

Vendor Selection Service

Implementing serialisation capabilities involves selecting a number of different vendors to provide different aspects of the end-to-end solution. Many of these purchases are significant and, for many companies, require a significant amount of rigor to ensure that the most appropriate providers are selected. We typically run vendor selection activities with our clients to:

  • Define requirements in the process
  • Understand the market place
  • Run the selection process
  • Engage with potential vendors for quotations
  • Select the appropriate vendor for our client’s situation
  • Agree appropriate contractual terms and service level agreements

For more information on this service, click here.

Other Serialisation Services

Be4ward provides various serialisation services that can help your company meet serialisation deadlines in a time effective and efficient manner:

EU FMD National Systems, EU FMD EU Hub Connection

Contact us

Should you have any questions about the EU FMD legislation, or would simply like to request a copy of any of our serialisation booklets, please don’t hesitate to contact us at enquiries@be4ward.com for more information.

Organisations Membership

As member of these renowned organisations, we ensure to provide services using the latest standards and good practices related to your business.

 

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Executive Briefing Avoiding the supply risk from serialisation with CMOs image

Executive Briefing: Avoiding the supply risk from serialisation with CMOs

For many Pharma companies, the use of contract manufacturing organisations (CMOs) to package commercial product is an integral part of their supply chain. Indeed, for virtual companies, it may be the only way their products are packaged. Be4ward has been implementing serialisation with Pharma companies and CMOs for many years. We have written this document to capture some of our learning throughout that journey and hope it will be useful to you, the reader.

Web-based Training Course: Packaging Artwork Document Verification and Proofreading

Getting artwork right is a critical requirement for companies providing products to healthcare providers and patients, whether they be pharmaceuticals, biologicals or medical devices manufacturers. This relies on having the right capabilities in place - processes, tools and skills. Proofreading is a key part of these capabilities.

'Artwork recall remains one of the highest causes of recall in the healthcare industry and carries the risk of serious consequences for patients.'

Pharmaceutical Artwork Proofreading can be seen as one of the last defences before the drug product is released to production, yet, few people involved in proofreading have had formal training in the different aspects of manual and electronic proofreading. Where else would you encounter a critical quality control task that was not supported by formal, recorded training?

This is the reason why Be4ward artwork experts have put together this one of a kind web-based training created to help artwork professionals, whether they are in artwork, central and local country regulatory, packaging engineering or other teams providing critical data to be fully capable and competent in this topic.

What will you learn?
Why taking this E-proofreading course?
Who should register?
How does it work?

The Main benefits of learning online

Send us your responses to set up a call with a serialization expert

Copy your responses to our  questions on the right into the form. We will get back to you shortly to set a 30-minute call with one of our Serialisation expert.

 

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Serialisation call questions
  • Question 1: What is your role with regard to serialisation for your organisation?
  • Question 2: What is the scope of your role, e.g. global, regional, site based?
  • Question 3: Please describe in a few sentences where your organisation is on their serialisation journey
  • Question 4: Are there any particular topics that you would like to focus on during a call with our serialisation expert?

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts' Blogs

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Serialisation Publishing

Responding To Serialisation Legislation

Pharmaceutical product serialisation legislation is being developed and approved across the World to help ensure patient safety and prevent reimbursement fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with the legislation will mean that companies cannot sell products in the affected markets. This White Paper explains this legislation, its impacts and describes how pharmaceutical companies should tackle the legislation in the most effective way.

DOWNLOAD NOW

Things we wish we had Known Before Starting a Serialisation Program or Project

While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded many lessons learnt and continues to do so. This booklet explains some of the key things that we wish we had known before embarking on our early projects.

DOWNLOAD NOW

Top 10 Tips for Developing a Serialisation Strategy

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company such as Regulatory and legislative management and government affairs, Packaging operations, Distribution operations and IT. These capabilities must be implemented effectively in a timely manner to ensure product supply is maintained. The following is a series of tips for developing and implementing your serialisation strategy.

DOWNLOAD NOW

Executive Briefing: Avoiding the supply risk from serialisation with CMOs

For many Pharma companies, the use of contract manufacturing organisations (CMOs) to package commercial product is an integral part of their supply chain. Indeed, for virtual companies, it may be the only way their products are packaged. Be4ward has been implementing serialisation with Pharma companies and CMOs for many years. We have written this document to capture some of our learning throughout that journey and hope it will be useful to you, the reader.

DOWNLOAD NOW

EU Falsified Medicines Directive: How to Develop a Comprehensive Plan with Rapid Implementation

The countdown to EU Falsified Medicines Directive (EU FMD) compliance is underway. With fewer than two years until the serialisation compliance deadline takes effect, industry serialisation leaders, Optel Group, Be4ward and Verify Brand, present a free 60-minute webinar for pharmaceutical organisations that must comply with EU FMD. The webinar, “How to Develop a Robust Plan with Rapid Implementation,” provides pharmaceutical companies with the tools to develop a comprehensive strategy and implementation plan in advance of the February 9, 2019 EU FMD compliance deadline.

DOWNLOAD NOW

10 Tips to Accelerate your EU Falsified Medicines Directive (FMD) Strategy

The countdown is well under way, with significantly less than two years until the EU Falsified Medicines Directive (EU FMD) serialisation compliance deadline – will your company be ready in time? With 32 countries across Europe being affected by this legislation, in this booklet we will discuss 10 tips to consider whilst developing and implementing your EU FMD serialisation strategy. Avoid supply interruption, make sure you have robust, realistic plans to address February 2019 EU FMD requirements.

DOWNLOAD NOW

Artwork Management Publishing

Do It Right The First Time: Reduce Compliance Risk and Streamline your Labeling and Artwork Processes into World-Class Capabilities

We all understand that packaging and artwork still present a significant compliance risk and delivering right first time artwork is a complex endeavor involving many moving parts. Furthermore, being right first time increases speed, reduces waste and raises confidence. Hear from a leading expert on how to increase patient safety, improve regulatory compliance and increase sales by providing error-free artwork and a streamlined Labeling process. Andrew Love will provide clear direction on how you can establish world-class labeling and artwork capabilities.

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Top 10 Right‑First‑Time Tips to Streamline and Improve Your Artwork Process

We all understand that packaging and artwork still present a significant compliance risk and delivering right‑first‑time artwork is a complex endeavour involving many moving parts. Furthermore, being right‑first‑time increases speed, reduces waste and raises confidence. From this booklet, we can see that achieving high right‑first‑time is doable, but there are many parts to be addressed, requiring focus and persistence. As such, right‑first‑time is as much a mindset as an outcome.

DOWNLOAD NOW

Top 20 Artwork Auditor Tips

We list the top 20 things to consider when auditing pharmaceutical packaging labelling and artwork content creation capabilities. The booklet is designed to help auditing professionals improve their auditing techniques.If you would like a hard copy of this booklet, please send us an email.

DOWNLOAD NOW

Reducing Packaging Recall Risk

Packaging artwork is a complex but often overlooked aspect in the design of pharmaceutical products. Unfortunately, packaging artwork errors are one of the main causes of product recalls. Many factors are driving companies to increase their product range. This brings with it a corresponding increase in the risk of artwork related recalls and near misses. In this white paper, we draw on our extensive experience of designing, implementing and managing global packaging artwork capabilities to help you understand how to minimise these risks.

DOWNLOAD NOW

Top 15 Causes of Proofreading Errors

Proofreading is a critical quality control step in the process of ensuring that the packaging labelling and artwork of finished pharmaceutical product is correct. Mistakes in this artwork can put patient safety at risk. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential to patient safety. This booklet identifies a number of errors which are typically seen in the design and execution of proofreading capabilities which should be avoided to ensure a quality proofreading result.

DOWNLOAD NOW

Artwork Key Learnings

Like all significant change activity, many artwork programmes commence, but not all are successful. Priorities change, resources are constrained, timelines can slip, funds can be withdrawn, and scope can be reduced: in other words, there are many different factors that can cause your artwork improvement project to fail. Over the years, we have learned many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. We have captured these key learnings in this booklet as useful tips to carry your Artwork Program forward. We hope these are useful in shaping your projects and delivering success to your companies.

DOWNLOAD NOW

Ensuring effective translation

As globalisation increases and companies reach customers in many more markets around the world, the need for accurate and comprehensive translations increases. Translation activity is an often forgotten back-room process. It is rarely considered core to a company’s operations, but failure in the process results in incorrect information being provided to customers, suppliers, regulators or shareholders. At minimum this is embarrassing and may not show the company in the best light. However some errors can be significant, impacting the safety of the customer or agreements with regulators. These can seriously damage the company’s reputation and lead to sanctions and fines. This booklet provides a series of tips to help you establish your translation capability based around a 10 step process.

DOWNLOAD NOW

EU Medical Device Regulation Publishing

An Introduction to the EU Medical Device Regulation (EU MDR)

Billed as the most significant changes to medical device legislation in decades, these regulations seek to increase the safety and effectiveness of medical devices available in the EU market and address weaknesses in the regulations revealed in several high profile incidents. Medical device and in vitro diagnostic device manufacturers large and small who supply product to the EU market will be impacted and need to start planning now on how to transition to the new requirements.

DOWNLOAD NOW

Supply Chain Packaging Publishing

Top 20 Packaging Complexity

Stock Keeping unit (SKU) and packaging component portfolio control is a critical activity for organisations. Ensuring the correct balance between a commercially advantageous portfolio, whilst minimising unnecessary pack and component variants is a challenge faced by many healthcare product companies as they grow their product range and expand into new markets. Therefore ensuring there are decision making processes in the organisation to manage required levels of complexity is a key aspect of effective pack management. This booklet takes the popular Top 20 Tips format to describe key features of a complexity management capability in an easy to digest format.

DOWNLOAD NOW

Legal Entity Publishing

Managing Product Licence and Packaging Changes Post Merger or Acquisition

We draw on our team’s award winning experience in the management of product licence and packaging changes in the aftermath of mergers and acquisitions to explain how to achieve this complex task whilst minimising supply risk and cost.

DOWNLOAD NOW

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Artwork-Key-Learnings-v4-Screen-1

Artwork Key Learnings

Like all significant change activity, many artwork programmes commence, but not all are successful. Priorities change, resources are constrained, timelines can slip, funds can be withdrawn, and scope can be reduced: in other words, there are many different factors that can cause your artwork improvement project to fail. Over the years, we have learned many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. We have captured these key learnings in this booklet as useful tips to carry your Artwork Program forward. We hope these are useful in shaping your projects and delivering success to your companies.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Ensuring-Effective-Translations-v5-Screen-1

Ensuring effective translations

As globalisation increases and companies reach customers in many more markets around the world, the need for accurate and comprehensive translations increases.Translation activity is an often forgotten back-room process. It is rarely considered core to a company’s operations, but failure in the process results in incorrect information being provided to customers, suppliers, regulators or shareholders. At minimum this is embarrassing and may not show the company in the best light. However some errors can be significant, impacting the safety of the customer or agreements with regulators. These can seriously damage the company’s reputation and lead to sanctions and fines. This booklet provides a series of tips to help you establish your translation capability based around a 10 step process.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

CoverWP-Legal-Restructuring-Post-MA-1sm-1

Managing Product Licence and Packaging Changes Post Merger or Acquisition

We draw on our team’s award winning experience in the management of product licence and packaging changes in the aftermath of mergers and acquisitions to explain how to achieve this complex task whilst minimising supply risk and cost.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Pack-Complexity-v6-Screen-1

Top 20 Packaging Complexity

Stock Keeping unit (SKU) and packaging component portfolio control is a critical activity for organisations. Ensuring the correct balance between a commercially advantageous portfolio, whilst minimising unnecessary pack and component variants is a challenge faced by many healthcare product companies as they grow their product range and expand into new markets. Therefore ensuring there are decision making processes in the organisation to manage required levels of complexity is a key aspect of effective pack management. This booklet takes the popular Top 20 Tips format to describe key features of a complexity management capability in an easy to digest format.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Proofreading-v5-Screen-1

Top 15 Causes of Proofreading Errors

Proofreading is a critical quality control step in the process of ensuring that the packaging labelling and artwork of finished pharmaceutical product is correct. Mistakes in this artwork can put patient safety at risk. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential to patient safety. This booklet identifies a number of errors which are typically seen in the design and execution of proofreading capabilities which should be avoided to ensure a quality proofreading result.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Top-Auditor-Tips-v4-Screen-1

Top 20 Artwork Auditor Tips

We list the top 20 things to consider when auditing pharmaceutical packaging labelling and artwork content creation capabilities. The booklet is designed to help auditing professionals improve their auditing techniques.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Top-10-Tips-for-Dev-strategy-v7-Screen-1

Top 10 Tips for Developing a Serialisation Strategy

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company such as Regulatory and legislative management and government affairs, Packaging operations, Distribution operations and IT. These capabilities must be implemented effectively in a timely manner to ensure product supply is maintained. The following is a series of tips for developing and implementing your serialisation strategy.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Things-we-wish-we-had-Known-v8-Screen-1

Things we wish we had Known Before Starting a Serialisation Project

While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded many lessons learnt and continues to do so. This booklet explains some of the key things that we wish we had known before embarking on our early projects.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

Cover-Reducing-Packaging-Recall-Risk-1sm-1

Reducing Packaging Recall Risk

Packaging artwork is a complex but often overlooked aspect in the design of pharmaceutical products. Unfortunately, packaging artwork errors are one of the main causes of product recalls. Many factors are driving companies to increase their product range. This brings with it a corresponding increase in the risk of artwork related recalls and near misses. In this white paper, we draw on our extensive experience of designing, implementing and managing global packaging artwork capabilities to help you understand how to minimise these risks.

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Download your white paper

CoverWPserialisationlegislation

Responding To Pharmaceutical Serialisation Legislation

Pharmaceutical product serialisation legislation is being developed and approved across the World to help ensure patient safety and prevent reimbursement fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with the legislation will mean that companies cannot sell products in the affected markets. This White Paper explains this legislation, its impacts and describes how pharmaceutical companies should tackle the legislation in the most effective way.

Andrew Love & Stephen McIndoe are world experts in developing excellent pharmaceutical and healthcare packaging labelling and artwork capabilities. They have helped a great number of pharma companies to transform their operation and mitigate their risks.

Andrew and Stephen share also their views and tips on their respective blogs with regular posts on all the topics related to Serialisation, Artwork, Proofreading, Packaging Supply Chain Optimization.

Visit their respective blog often and share their posts with your teams.

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Be-Strategic: Serialisation Strategy Development

Be4ward's strategy development service brings together a number of our serialisation products to help organisations develop an initial understanding of how to tackle serialisation. Typically, strategy development would include:

  • Understanding of the current and future legislation
  • Impact of the legislation on the company's supply chain, including any opportunities that might present
  • Initial high level designs of the serialisation solution architecture
  • High level roadmap for managing these impacts and the resulting new capabilities that will need to be put in place
  • Cost and resource impact estimation
  • Plan for the next phase of activity

Given the situation that some organisations find themselves in, it may also be appropriate to develop some key documents in parallel with the strategy activity to ensure effective mobilisation of the program. These might include such things as key User Requirements specifications and supplier selection documents.

It must not be forgotten that the environment within which serialisation operates changes over time. Legislation is clearly evolving, but also a company's products and supply chain also evolves over time. Therefore, organisations need to consider how they periodically refresh their serialisation strategy on an ongoing basis.

Be-Supplied: Defining the optimal supply chain to deliver serialisation

Serialisation is a costly undertaking and, for many organisations, simply serialising their existing supply chain is not an economic proposition. Indeed, for many organisations, serialisation can be a catalyst to changing the way in which their packaging supply chain is configured.

Be4ward has a great deal of experience in defining alternative supply models to optimise the overall cost and impact of serialisation. Some of these options can be adopted for tactical reasons, to get over otherwise insurmountable short term deadlines or serialise low volume products. Whilst others provide long term opportunity to reconfigure the supply chain.

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Artwork

Are your Artwork capabilities healthy?

We can help you

We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

Request a hard copy

Fill in the form to receive our publishing by mail.

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts' Blogs

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Serialisation Publishing

Responding To Serialisation Legislation

Pharmaceutical product serialisation legislation is being developed and approved across the World to help ensure patient safety and prevent reimbursement fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with the legislation will mean that companies cannot sell products in the affected markets. This White Paper explains this legislation, its impacts and describes how pharmaceutical companies should tackle the legislation in the most effective way.

Download

Things we wish we had Known Before Starting a Serialisation Program or Project

While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded many lessons learnt and continues to do so. This booklet explains some of the key things that we wish we had known before embarking on our early projects.

Download

Top 10 Tips for Developing a Serialisation Strategy

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company such as Regulatory and legislative management and government affairs, Packaging operations, Distribution operations and IT. These capabilities must be implemented effectively in a timely manner to ensure product supply is maintained. The following is a series of tips for developing and implementing your serialisation strategy.

Download

Artwork Management Publishing

Top 20 Artwork Auditor Tips

We list the top 20 things to consider when auditing pharmaceutical packaging labelling and artwork content creation capabilities. The booklet is designed to help auditing professionals improve their auditing techniques.If you would like a hard copy of this booklet, please send us an email.

Download

Reducing Packaging Recall Risk

Packaging artwork is a complex but often overlooked aspect in the design of pharmaceutical products. Unfortunately, packaging artwork errors are one of the main causes of product recalls. Many factors are driving companies to increase their product range. This brings with it a corresponding increase in the risk of artwork related recalls and near misses. In this white paper, we draw on our extensive experience of designing, implementing and managing global packaging artwork capabilities to help you understand how to minimise these risks.

Download

Top 15 Causes of Proofreading Errors

Proofreading is a critical quality control step in the process of ensuring that the packaging labelling and artwork of finished pharmaceutical product is correct. Mistakes in this artwork can put patient safety at risk. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential to patient safety. This booklet identifies a number of errors which are typically seen in the design and execution of proofreading capabilities which should be avoided to ensure a quality proofreading result.

Download

Supply Chain Packaging Publishing

Top 20 Packaging Complexity

Stock Keeping unit (SKU) and packaging component portfolio control is a critical activity for organisations. Ensuring the correct balance between a commercially advantageous portfolio, whilst minimising unnecessary pack and component variants is a challenge faced by many healthcare product companies as they grow their product range and expand into new markets. Therefore ensuring there are decision making processes in the organisation to manage required levels of complexity is a key aspect of effective pack management. This booklet takes the popular Top 20 Tips format to describe key features of a complexity management capability in an easy to digest format.

Download

Legal Entity Publishing

Managing Product Licence and Packaging Changes Post Merger or Acquisition

We draw on our team’s award winning experience in the management of product licence and packaging changes in the aftermath of mergers and acquisitions to explain how to achieve this complex task whilst minimising supply risk and cost.

Download


curious
thoughtful
insightful
perceptive
challenging
rigorous
excellent

Be

Serialisation, Artwork Management and Supply Chain Strategy
for Pharma, Biotech and Medical Devices Industries

Executive Briefing

Avoiding the supply risk from
serialisation with CMOs

Download Now

DSCSA & EU FMD now live

Speak 1:1 with a Serialisation Expert for free

Where are we?

MAKING PHARMA 2019

Be4ward’s expert speakers at Making
Pharma Conference 2019

Register Now

2018-Winners-Logo-Landscape

BE4WARD AWARD WINNING

Slide background

Artwork Error - A significant recall risk

Is your process world class?

Get the best information

Read our book, booklets
and white papers

Download now

Welcome

Serialisation strategy to implementation

slider2.2

Artwork

artwork

Packaging design process & supply chain

medicine

Blog, Training, Videos and Publications

resources

What We Do

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.

We deliver value to our clients thorough a combination of deep subject matter expertise and excellent consulting skills.

Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

 

 

Our Areas of Focus
  • Product coding, serialization and anti-counterfeiting capabilities
  • Packaging and artwork design capabilities
  • Post merger legal or acquisition brand integration
  • Secondary packaging and distribution supply chain design
  • Product complexity management, late customization and postponement
  • Pharmaceutical product launch and portfolio management
Global Coverage
 GlobeBe4ward provides specialist consulting assistance to clients across the globe. We are happy to work at your location(s), remotely or in a combination of the two.

 

Get in touch with us

[/dt_sc_fullwidth_section]

Get in touch with us

Contact us now for more information to start your Project or Program

Our Experts Blogs

Andrew and Stephen share their views and tips on their respective blogs with regular posts on all the topics related to Serialisation, Artwork, Proofreading, Packaging Supply Chain Optimization.

Visit their respective blog often and share their posts with your teams.

Andrew Love
Vice-President

See Andrew's particular take on Artwork Management, Translation and Proofreading Practices.

See Andrew's Blog
Stephen McIndoe
Vice-President

See Stephen tips and take on Serialisation and Packaging Supply Chain Optimization Practices.

See Stephen's Blog
Organisations Membership
[/dt_sc_fullwidth_section]
Training Courses & Events

Be4ward provides online and on-site specialized training courses on Serialization, Artwork Management and Packaging Supply Chain topics.

Our experienced professionals team can provide a standard or à la carte course to fit your specific needs.

Click below to get more information on all our training courses for you and your team.

Get more info on trainings now
Our Expert's Publishing

publishing_hpge

At Be4ward, we pride ourselves on sharing our knowledge issued from many years of experience.

Download our booklets and white papers on Serialisation, Artwork and Packaging Supply Chain topics.

Our reference book Sustaining Excellent Packaging Labelling and Artwork capabilities, is also available on Amazon.com

See our Publications & Free downloads
Our Labelling and Artwork book

bouton-coverbooksm

SUSTAINING EXCELLENT PACKAGING LABELLING AND ARTWORK CAPABILITIES BOOK

Understand and deliver the right mix of packaging artwork capabilities for your organisation, faster, at lower cost and with significantly less risk. You will find:

The importance of artwork capabilities in the business strategy The causes of artwork errors Contain all the crucial elements needed in your artwork capability implementation Discover what the future holds Buy this book now

“If you are looking to improve the performance of your company’s artwork capabilities then this book is a must read. It captures the authors’ vast experience in turning around the artwork operations of healthcare companies and provides a unique and valuable resource for anyone involved in the area.”

– Steve Richmond
Head of Global Packaging, AstraZeneca
[/dt_sc_icon_box][/dt_sc_one_third][/dt_sc_fullwidth_section]
Consulting Services
slider2.2

Products Serialisation
Whether you are already on your serialisation journey, or just embarking on it, Be4ward has a broad range of consulting services to help your Serialisation Program/Projects/Operations be successful.

Learn More

artwork

Artwork Management
Packaging labeling and artwork present a significant compliance risk. Be4ward helps companies to get world class capabilities to mitigate this risk and reduce their level of recalls.

Learn More

medicine

Packaging Supply Chain Optimization
Be4ward has helped a number of clients to optimize their product portfolio and packaging range. They also designed optimal packaging supply chains to deliver high degrees of customer service for small order quantities.

Learn More

legalentitysm

Legal Entity and Brand Integration
Be4ward has a proven approach tool kit and experienced consultants to help companies successfully manage their legal entity and brand integration projects.

Learn More
About Be4ward

What we do

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.

We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills.

Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

Areas of focus

Product coding, serialization and anti-counterfeiting capabilities Packaging and artwork design capabilities Post merger legal or acquisition brand integration Secondary packaging and distribution supply chain design Product complexity management, late customization and postponement Pharmaceutical product launch and portfolio management

Global Coverage

Be4ward provides specialist consulting assistance to clients across the globe. Our teams are mainly based in Europe and North America.

We can work at your location(s), remotely or in a combination of the two.


curious
thoughtful
insightful
perceptive
challenging
rigorous
excellent

Be

Serialisation, Artwork Management and Supply Chain Strategy
for Pharma, Biotech and Medical Devices Industries

Executive Briefing

Avoiding the supply risk from
serialisation with CMOs

Download Now

DSCSA & EU FMD now live

Speak 1:1 with a Serialisation Expert for free

Where are we?

MAKING PHARMA 2019

Be4ward’s expert speakers at Making
Pharma Conference 2019

Register Now

2018-Winners-Logo-Landscape

BE4WARD AWARD WINNING

Slide background

Artwork Error - A significant recall risk

Is your process world class?

Get the best information

Read our book, booklets
and white papers

Download now


curious
thoughtful
insightful
perceptive
challenging
rigorous
excellent

Be

Serialisation, Artwork Management and Supply Chain Strategy
for Pharma, Biotech and Medical Devices Industries

Executive Briefing

Avoiding the supply risk from
serialisation with CMOs

Download Now

DSCSA & EU FMD now live

Speak 1:1 with a Serialisation Expert for free

Where are we?

MAKING PHARMA 2019

Be4ward’s expert speakers at Making
Pharma Conference 2019

Register Now

2018-Winners-Logo-Landscape

BE4WARD AWARD WINNING

Slide background

Artwork Error - A significant recall risk

Is your process world class?

Get the best information

Read our book, booklets
and white papers

Download now

About Be4ward

What we do

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.

We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills.

Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

Areas of focus

  • Product coding, serialization and anti-counterfeiting capabilities
  • Packaging and artwork design capabilities
  • Post merger legal or acquisition brand integration
  • Secondary packaging and distribution supply chain design
  • Product complexity management, late customization and postponement
  • Pharmaceutical product launch and portfolio management

Global Coverage

 Be4ward provides specialist consulting assistance to clients across the globe. Our teams are mainly based in Europe and North America.

We can work at your location(s), remotely or in a combination of the two.

Consulting Services
slider2.2

‘Product Serialisation
Whether you are already on your serialisation journey, or just embarking on it, Be4ward has a broad range of consulting services to help your Serialisation Program/Projects/Operations be successful.

Learn MoreEU FMD

medicine

Packaging Supply Chain Optimization
Be4ward has helped a number of clients to optimize their product portfolio and packaging range. They also designed optimal packaging supply chains to deliver high degrees of customer service for small order quantities.

Learn More

medicine

EU MEDICAL DEVICE REGULATION
The requirements for the new legislation impact the majority of parties involved in the supply and governance of medical devices to the EU market across the entire lifecycle of each device. Be4ward can help you understand and implement solutions.

Learn More

artwork

Labelling and Artwork Management
Packaging labelling and artwork present a significant compliance risk. Be4ward helps companies to get world class capabilities to mitigate this risk and reduce their level of recalls.

Learn More

legalentitysm

Legal Entity and Brand Integration
Be4ward has a proven approach tool kit and experienced consultants to help companies successfully manage their legal entity  and brand integration projects.

Learn More

Get in touch with us

Contact us now for more information to start your Project or Program

Our Expert's Publishing
Specialist Labelling and Artwork

At Be4ward, we pride ourselves on sharing our knowledge issued from many years of experience.

Download our booklets and white papers on Serialisation, Artwork and Packaging Supply Chain topics.

Our reference book Sustaining Excellent Packaging Labelling and Artwork capabilities,  is also available on Amazon.com

See our Publications & Free downloads

Our Labelling and Artwork book

Labelling and Artwork Specialist

SUSTAINING EXCELLENT PACKAGING LABELLING AND ARTWORK CAPABILITIES BOOK

Understand and deliver the right mix of packaging artwork capabilities for your organisation, faster, at lower cost and with significantly less risk. You will find:

  • The importance of artwork capabilities in the business strategy
  •  The causes of artwork errors
  • Contain all the crucial elements needed in your artwork capability implementation
  • Discover what the future holds

Buy this book now

“If you are looking to improve the performance of your company’s artwork capabilities then this book is a must read. It captures the authors’ vast experience in turning around the artwork operations of healthcare companies and provides a unique and valuable resource for anyone involved in the area.”

– Steve Richmond
Head of Global Packaging, AstraZeneca
Training Courses & Events

Be4ward  provides online and on-site specialized training courses on Serialization, Artwork Management and Packaging Supply Chain topics.

Our experienced professionals team can provide a standard or à la carte course to fit your specific needs.

Click below to get more information on all our training courses for you and your team.

Get more info on trainings now

Our Experts Blogs

Andrew and Stephen share their views and tips on their respective blogs with regular posts on all the topics related to Serialisation, Artwork, Proofreading, Packaging Supply Chain Optimization.

Visit their respective blog often and share their posts with your teams.

Andrew Love
Vice-President

See Andrew's particular take on Artwork Management, Translation and Proofreading Practices.

See Andrew's Blog

 

Stephen McIndoe
Vice-President

See Stephen tips and take on Serialisation and Packaging Supply Chain Optimization Practices.

See Stephen's Blog
Organisations Membership

We pride ourselves on sharing our knowledge

Along with transferring our knowledge when delivering change projects, we also provide other training services.
Training Services

Be4ward offers standard and personalized courses to fit your needs and your teams:

  • Be4ward can provide on-site courses on a wide variety of topics related to Serialisation, Artwork and Packaging Supply Chain Management
  • You can also access online courses prepared by Experts from the industry for self study work with a training record certificate.
Education

Be4ward have produced many publications available on the Experts' Publishing section under white papers and booklets format. These publications are also available in print if required by simply fill in the contact form.

Stephen McIndoe and Andrew Love are also co-authors of the book ‘Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities’, available on Amazon.com.

Sign-up to an e-learning course

Seamless legal entity integration

Mergers and acquisitions represent both opportunities and significant risks if the integration of legal entities are not done efficiently and effectively. A post-merger/acquisition integration program needs to deliver an optimal and tax-efficient legal structure, with appropriately revised local product registrations and product labelling changes, without impacting the free flow of product to the customers or incurring unnecessary cost.

Be4ward has a proven approach tool kit and experienced consultants to help companies successfully manage legal entity and brand integration projects.

legal_capabilities

Illustrative Integration Program Approach


curious
thoughtful
insightful
perceptive
challenging
rigorous
excellent

Be

Serialisation, Artwork Management and Supply Chain Strategy
for Pharma, Biotech and Medical Devices Industries

Executive Briefing

Avoiding the supply risk from
serialisation with CMOs

Download Now

DSCSA & EU FMD now live

Speak 1:1 with a Serialisation Expert for free

Where are we?

MAKING PHARMA 2019

Be4ward’s expert speakers at Making
Pharma Conference 2019

Register Now

2018-Winners-Logo-Landscape

BE4WARD AWARD WINNING

Slide background

Artwork Error - A significant recall risk

Is your process world class?

Get the best information

Read our book, booklets
and white papers

Download now

[dt_sc_contact-III /]
[dt_sc_contact-I /]
About Be4ward

What we do

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.

We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills.

Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

 

 

Areas of focus

  • Product coding, serialization and anti-counterfeiting capabilities
  • Packaging and artwork design capabilities
  • Post merger legal or acquisition brand integration
  • Secondary packaging and distribution supply chain design
  • Product complexity management, late customization and postponement
  • Pharmaceutical product launch and portfolio management

Global Coverage

 Be4ward provides specialist consulting assistance to clients across the globe. We can work at your location(s), remotely or in a combination of the two.

 

 

 

 

 

 

 

Consulting Services

slider2.2

Products Serialisation
Whether you are already on your serialisation journey, or just embarking on it, Be4ward has a broad range of consulting services to help your Serialisation Program/Projects/Operations be successful.

Learn More

artwork

Artwork Management
Packaging labeling and artwork present a significant compliance risk. Be4ward helps companies to get world class capabilities to mitigate this risk and reduce their level of recalls.

 

Learn More

medicine

Packaging Supply Chain Optimization
Be4ward has helped a number of clients to optimize their product portfolio and packaging range. They also designed optimal packaging supply chains to deliver high degrees of customer service for small order quantities. 

Learn More

legal_entityhp

Legal Entity and Brand Integration
Be4ward has a proven approach tool kit and experienced consultants to help companies successfully manage their legal entity  and brand integration projects.

Learn More

Contact us

Get in touch now for more information to start your Project or Program

Our Expert's Publishing

At Be4ward, we pride ourselves on sharing our knowledge issued from many years of experience.

Download our booklets and white papers on Serialisation, Artwork and Packaging Supply Chain topics.

Our reference book Sustaining Excellent Packaging Labelling and Artwork capabilities,  is also available on Amazon.com

See our Publications & Free downloads

image004

SUSTAINING EXCELLENT PACKAGING LABELLING AND ARTWORK CAPABILITIES BOOK

Understand and deliver the right mix of packaging artwork capabilities for your organisation, faster, at lower cost and with significantly less risk. You will find:

  • The importance of artwork capabilities in the business strategy
  •  The causes of artwork errors
  • Contain all the crucial elements needed in your artwork capability implementation
  • Discover what the future holds

Buy this book now

Training Courses & Events

Be4ward  provides online and on-site specialized training courses on Serialization, Artwork Management and Packaging Supply Chain topics.

Our experienced professionals team can provide a standard or à la carte course to fit your specific needs.

Click below to get more information on all our training courses for you and your team.

Get more info on trainings now

Our Experts Blogs

Andrew and Stephen share their views and tips on their respective blogs with regular posts on all the topics related to Serialisation, Artwork, Proofreading, Packaging Supply Chain Optimization.

Visit their respective blog often and share their posts with your teams..

Andrew Love
Vice-President

See Andrew's particular take on Artwork Management, Translation and Proofreading Practices.

Stephen McIndoe
Vice-President

See Stephen tips and take on Serialisation and Packaging Supply Chain Optimization.

Organisations Membership


curious
thoughtful
insightful
perceptive
challenging
rigorous
excellent

Be

Serialisation, Artwork Management and Supply Chain Strategy
for Pharma, Biotech and Medical Devices Industries

Executive Briefing

Avoiding the supply risk from
serialisation with CMOs

Download Now

DSCSA & EU FMD now live

Speak 1:1 with a Serialisation Expert for free

Where are we?

MAKING PHARMA 2019

Be4ward’s expert speakers at Making
Pharma Conference 2019

Register Now

2018-Winners-Logo-Landscape

BE4WARD AWARD WINNING

Slide background

Artwork Error - A significant recall risk

Is your process world class?

Get the best information

Read our book, booklets
and white papers

Download now

[dt_sc_contact-III /]
[dt_sc_contact-I /]
About Be4ward

What we do

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.

We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills.

Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

 

 

Areas of focus

  • Product coding, serialization and anti-counterfeiting capabilities
  • Packaging and artwork design capabilities
  • Post merger legal or acquisition brand integration
  • Secondary packaging and distribution supply chain design
  • Product complexity management, late customization and postponement
  • Pharmaceutical product launch and portfolio management

Global Coverage

 Be4ward provides specialist consulting assistance to clients across the globe. We can work at your location(s), remotely or in a combination of the two.

 

 

 

 

 

 

 

Consulting Services

slider2.2

Serialisation
Whether you are already on your serialisation journey, or just embarking on it, Be4ward has a broad range of consulting services to help your program/projects/operations be successful.

Learn More

artwork

Artwork Management
Packaging and artwork present a significant compliance risk. Be4ward helps companies to get the right capabilities to mitigate risk and reduce their level of recalls.

 

Learn More

medicine

Packaging Supply Chain Optimization
Keeping your Packaging Supply Chain operations healthy is mandatory to face the ever increasing level of complexity required.

Learn More

legal_entityhp

Legal Entity and Brand Integration
Do you have the capabilities required to deal with post‑merger and acquisition challenges? We do…

Learn More

Contact us

Get in touch now for more information to start your Project or Program

Our Publishing

At Be4ward, we pride ourselves on sharing our knowledge issued from many years of experience.

Download our booklets and white papers on Serialisation, Artwork and Packaging Supply Chain topics.

Our book Sustaining excellent packaging labelling and artwork capabilities, a reference on the matter, is also available on Amazon.com

See our Publications & Free downloads

image004

SUSTAINING EXCELLENT PACKAGING LABELLING AND ARTWORK CAPABILITIES BOOK

Understand and deliver the right mix of packaging artwork capabilities for your organisation, faster, at lower cost and with significantly less risk. You will find:

  • The importance of artwork capabilities in the business strategy
  •  The causes of artwork errors
  • Contain all the crucial elements needed in your artwork capability implementation
  • Discover what the future holds

Buy this book now

Training Courses & Events

Be4ward made a specialty to provide online and on-site specialized training courses on Serialization, Artwork Management and Packaging Supply Chain topics.

The experienced professional team can provide a formatted course or à la carte to fit your specific needs.

Send us an email to get more information on all our training courses for you and your team.

Get more info on trainings now

Our Experts Blogs

Andrew and Stephen share their views and tips on their respective blogs with regular posts on all the topics related to Serialisation, Artwork, Proofreading, Packaging Supply Chain Optimization.

Visit their respective blog often and share their posts with your teams..

Andrew Love
Vice-President

See Andrew's particular take on Artwork Management, Translation and Proofreading Practices.

Stephen McIndoe
Vice-President

Discover the tips and the rich experience of Stephen to put Serialisation and Packaging Supply Chain Optimization first.

Organisations Membership


curious
thoughtful
insightful
perceptive
challenging
rigorous
excellent

Be

Serialisation, Artwork Management and Supply Chain Strategy
for Pharma, Biotech and Medical Devices Industries

Executive Briefing

Avoiding the supply risk from
serialisation with CMOs

Download Now

DSCSA & EU FMD now live

Speak 1:1 with a Serialisation Expert for free

Where are we?

MAKING PHARMA 2019

Be4ward’s expert speakers at Making
Pharma Conference 2019

Register Now

2018-Winners-Logo-Landscape

BE4WARD AWARD WINNING

Slide background

Artwork Error - A significant recall risk

Is your process world class?

Get the best information

Read our book, booklets
and white papers

Download now

[dt_sc_contact-III /]
[dt_sc_contact-I /]
About Be4ward

What we do

Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.

We deliver value to our clients through a combination of deep subject matter expertise and excellent consulting skills.

Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

Areas of focus

  • Product coding, serialization and anti-counterfeiting capabilities
  • Packaging and artwork design capabilities
  • Post merger legal or acquisition brand integration
  • Secondary packaging and distribution supply chain design
  • Product complexity management, late customization and postponement
  • Pharmaceutical product launch and portfolio management

Global Coverage

 Be4ward provides specialist consulting assistance to clients across the globe. We can work at your location(s), remotely or in a combination of the two.

 

 

 

 

 

 

 

Consulting Services

slider2.2

Serialisation
Whether you are already on your serialisation journey, or just embarking on it, Be4ward has a broad range of consulting services to help your Program/Projects/Operations be successful.

Learn More

artwork

Artwork Management
Packaging and artwork present a significant compliance risk. Be4ward helps companies to get the right capabilities to mitigate risk and reduce their level of recalls.

 

Learn More

medicine

Packaging Supply Chain Optimization
Keeping your Packaging Supply Chain operations healthy is mandatory to face the ever increasing level of complexity required.

Learn More

legal_entityhp

Legal Entity and Brand Integration
Do you have the capabilities required to deal with post‑merger and acquisition challenges? We do…

Learn More

Contact us

Get in touch now for more information to start your project or program
Our Publishing

At Be4ward, we pride ourselves on sharing our knowledge issued from many years of experience.

Download our booklets and white papers on Serialisation, Artwork and Packaging Supply Chain topics.

Our book  Sustaining excellent packaging labelling and artwork capabilities, a reference on the matter, is also available on Amazon.com

See our Publications & Free downloads

image004
SUSTAINING EXCELLENT PACKAGING LABELLING AND ARTWORK CAPABILITIES BOOK

Understand and deliver the right mix of packaging artwork capabilities for your organisation, faster, at lower cost and with significantly less risk. You will find:

  • The importance of artwork capabilities in the business strategy
  • The causes of artwork errors
  • Contain all the crucial elements needed in your artwork capability implementation
  • Discover what the future holds

Buy this book now

Training Courses & Events

Be4ward made a specialty to provide online and on-site specialized training courses on Serialization, Artwork Management and Packaging Supply Chain topics.

The experienced professional team can provide a formatted course or à la carte to fit your specific needs.

Send us an email to get more information on all our training courses for you and your team.

Get more info on trainings now

Our Experts Blogs

Andrew and Stephen share their views and tips on their respective blogs with regular posts on all the topics related to Serialisation, Artwork, Proofreading, Packaging Supply Chain Optimization.

Visit their respective blog often and share their posts with your teams..

Andrew Love
Vice-President

See Andrew's particular take on Artwork Management, Translation and Proofreading Practices.

image001-300x211

Stephen McIndoe
Vice-President

Discover the tips and the rich experience of Stephen to put Serialisation and Packaging Supply Chain Optimization first.

Organisations Membership

Understanding the Complexities of Serialisation

Coming this fall, a complete series to help you better prepare for your serialisation project.

Stephen McIndoe, award winning serialisation specialist, will walk you through the many lessons learnt and complexities that you may encounter on your own serialisation journey. Stephen has worked with many companies to develop serialisation strategy, design solutions and manage implementation programs. As a professional engineer with over 25 years of experience working for the world’s largest global life sciences companies as an employee and management consultant, you are sure to get the information you need to help you move forward.

Join us this fall for the first installment of this series where we will explore strategy implementation. If you have any questions about this series please contact us at: enquiries@be4ward.com

Price: 499 USD

Topics covered in this series include:

 

serialisation

Developing strategy to ensure companies continue to meet challenges of an ever changing business environment.
Click on the tabs below to read about these success stories.
Global Packaging Design Capability Strategy Development
Top 5 Global Pharma Company.
Situation
The company wanted to reduce it’s recall rate due to packaging design, whilst at the same time be able to understand and reduce the complexity of it’s pack range and associated components. The company’s packaging and artwork design capability had evolved over many years into a complex, disparate global collection of operations which made the task almost impossible to achieve.
How We Helped
Members of our team ran a strategy development project which delivered the following: •   Full understanding of the complex current situation •   Future state operating model, including a global service center network •   IT architecture to support the new operations •   Change programme design to deliver the new capabilities •   Buy-in from more than 300 stakeholders across the world to the recommendations
The Results
The company went on to implement this strategy in it’s entirety.

 

 

 

Serialization Strategy Development
Top 5 Global Pharma Company.
Situation
This global company recognised that there were a number of pieces of legislation beginning to emerge which required individual packs to be uniquely identified and tracked in different ways. Up until this point, a number of individual, uncoordinated initiatives had been initiated to deal with individual pieces of legislation. The company did not have a clear understanding of what serialisation was. Nor did it have an understanding of how to manage the implementation of these requirements. What it did suspect was that it was at risk of non-compliance if it did not get to grips with this emerging area. It also recognised that the costs of not reacting in a coordinated way could be huge.
How We Helped
Members of our team ran a strategy development project which delivered the following:

• An understanding of the disparate activities that had been going on in the company.

• Future state operating model, including regulatory tracking, standards development involvement, project and programme initiation and execution capability.

• IT architecture to support the new operations.

• New serialization management organisation design.

• New serialization governance model.

• Pilot projects.

• Plan to implement the above.

• Buy in from more than 100 stakeholders to the recommendations.

 
The Results
The strategy was implemented in it’s entirety. One of our team members went on to run the new serialization organisation for two years.

 

 

 

Solid Dose Packaging Strategy

Top 5 Global Pharma business.

Situation

The company had a global network of solid dose formulation and packaging sites. The majority of these sites supplied a small number of brands on a global basis. This network design was creating a number of inefficiencies:

  • Packaging capacity was not optimised.
  • Component formats and sizes were locally defined.
  • Regional legislation (e.g. Braille) impacted the global supply network.
  • Best practice was not being shared.
  • Equipment design and sourcing was undertaken locally.
  • Product was distributed globally to local in-country warehouses, resulting in high working capital and shipping costs.

How We Helped

Members of our team led the development of a global solid dose supply strategy leading to a move to regional packaging and distribution hubs. In this we:

  • Mapped the existing supply chain and portfolio to determine product flows, volumes and costs.
  • Defined and evaluated to-be network options.
  • Led the assessment of suitable hub locations.
  • Designed and sized the packaging and warehouse operations in each hub.
  • Reviewed and rationalised the product and component portfolios.
  • Defined the business case and facilitated approval.
  • Transitioned the programme into implementation.

The results

Gained approval for a GBP50m rationalisation of packaging locations and supply chain, refocusing to a regional packaging model, including:

  • Development of new packaging processes, organisational model and capabilities to achieve industry best-practice KPIs whilst ensuring compliance to legislative trends.
  • Standardisation of packaging equipment (50% reduction), components (75% reduction) and SKUs (40% reduction).
  • Simplification of downstream supply chains through a multi-market warehouse model.

 

 

 

Product portfolios are becoming more complex. Supply chains are becoming more fragmented. Volumes are reducing as Pharma Companies deliver ever more complex but expensive products. Traditional supply chains are tailored to shipping cases, pallets and containers. The new Pharma model requires something much more responsive and agile.

Our team have proven experience in delivering solutions to these challenges:

  • Regional packaging and distribution hubs
  • Multi-market products
  • Late stage customisation

We have developed and implemented new supply chain and product designs to help companies deal with their ever increasing complexity.

Click on the tabs below to read about these success stories.

Solid Dose Packaging Strategy
Top 5 Global Pharma Company.
Situation
The company had a global network of solid dose formulation and packaging sites. The majority of these sites supplied a small number of brands on a global basis. This network design was creating a number of inefficiencies:
  • Packaging capacity was not optimised.
  • Component formats and sizes were locally defined.
  • Regional legislation (e.g. Braille) impacted the global supply network.
  • Best practice was not being shared.
  • Equipment design and sourcing was undertaken locally.
  • Product was distributed globally to local in-country warehouses, resulting in high working capital and shipping costs.
How We Helped
Members of our team led the development of a global solid dose supply strategy leading to a move to regional packaging and distribution hubs. In this we:
  • Mapped the existing supply chain and portfolio to determine product flows, volumes and costs.
  • Defined and evaluated to-be network options.
  • Led the assessment of suitable hub locations.
  • Designed and sized the packaging and warehouse operations in each hub.
  • Reviewed and rationalised the product and component portfolios.
  • Defined the business case and facilitated approval.
  • Transitioned the programme into implementation.
The results
Gained approval for a GBP50m rationalisation of packaging locations and supply chain, refocusing to a regional packaging model, including:
  • Development of new packaging processes, organisational model and capabilities to achieve industry best-practice KPIs whilst ensuring compliance to legislative trends.
  • Standardisation of packaging equipment (50% reduction), components (75% reduction) and SKUs (40% reduction).
  • Simplification of downstream supply chains through a multi-market warehouse model.

 

 

Late Pack Customisation for small volume blister packs
Top 5 Global Pharma Company.
Situation
The company had a significant portfolio of blister packs with unpredictable demand and extremely small order volumes. Minimum order quantities resulted in many months forward cover and high obsolescence risk.
 
How we helped
Members of our team delivered an innovative packaging design that allowed small volume product to be late customized with local language labelling and product information.
  1. We established the project team comprising commercial, regulatory, manufacturing, supply chain, quality, packaging design, equipment design and equipment suppliers.
  2. We established the necessary cross-functional governance.
  3. We co-ordinated implementation.
The results
Increased market sales through better availability of product. Reduced working capital and obsolescence.
This project won a Starpack Gold Star Award for Late Pack Customisation.

 

 

 

Be-Educated: Serialisation education for the whole team

Serialisation education is critical to ensure that all members of your team can contribute efficiently and effectively to your serialisation activities.

From senior steering team members to packaging line operators, they all need to receive the appropriate serialisation education to contribute effectively and make the myriad of decisions they need too as part of their role.

Be4ward offers a number of education products to assist you in ensuring that your team members have the appropriate level of knowledge to contribute effectively to your serialisation activities, including:

Serialisation education workshops

  • Serialisation education webinars
  • Serialisation team member education coaching
  • Bespoke education events and materials development

Don't hesitate to contact us to discuss your needs.

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Be-Resourced

Serialisation is a relatively new topic and the pool of people who have the relevant skills and experience in the area are becoming increasingly difficult to find as the demand for their services mushrooms.

Be4ward has access to a broad range of suitably skilled and experience team members and can provide these people to clients either on a full or part time basis. The types of people we typically provide to clients include:

  • Senior subject matter experts
  • IT architects
  • Business analysts
  • Equipment engineers
  • Validation specialists
  • Program and project managers

If you are struggling to design your team or staff, please do not hesitate to contact our resourcing team and discuss how we might be able to help.

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Be-Governed: Establishing effective serialization governance

For any serialisation program to be successful, governance needs to be put in place across all the parties involved to ensure that decisions are made, and activity is coordinated, in a manner that will lead to timely implementation of the end-to-end solutions. In the lack of such governance, it is all too easy for local teams to make their own interpretations of legislation, define solutions and timelines in isolation, resulting in the end-to-end solution that does not work.

Be4ward has extensive experience establishing and supporting serialisation steering and governance teams, including such aspects as:

  • Designing governance/steering teams
  • Coaching and preparing for meetings
  • Facilitating significant decision making
  • Managing senior stakeholders
  • Facilitating meetings
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Be-Operational: Establishing effective ongoing operations and support

As a serialisation program progresses through initial implementations, the need to operationalise the new capabilities will become necessary. Many aspects of the new serialisation capabilities can be absorbed into existing organisation responsibilities. However, serialisation will often require some new or significantly enhanced support capabilities to be put in place.

If this requirement is not dealt with early in the life of a serialisation program, there is a significant risk that the program and project teams will be pulled away from their new capability implementation activity to deal with operational troubleshooting. Whilst solving the immediate operational serialisation needs, this will inevitably result in risk to the delivery of new capabilities.

Be4ward has experience in helping clients define and design support capabilities that address the particular cross-functional and often cross-organisation issues associated with end-to-end serialisation solutions.

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The core of most serialisation activity for many organisations is running a program of projects to put a variety of different capabilities in place. Be4ward works with many organisations to help deliver all aspects of this implementation activity.

Be-Designed

Designing the most appropriate solutions, be they serialisation packaging line systems, enterprise EPCIS systems or the myriad of other capabilities that are required for an effective end-to-end serialisation solution is at the core of what the Be4ward team of serialisation subject matter experts do.

We have experience in designing the most appropriate solutions for our clients no matter how large or small their organisation is, however complex or straight forward it may be. We are also very used to dealing with virtual organisations, where many of the capabilities that are required will need to be delivered through third party organisations such as contract manufacturers and logistics providers.

The end result of much of the design process is a set of design documents. Through our extensive experience, our team has developed a number of tools that help us ensure that we can help clients author comprehensive design documentation in a timely and efficient manner.

Be4ward prides itself on its independence from the supply base. This allows us to help clients make the impartial decisions that are critical to their success.

Be-Selective: Selecting the appropriate suppliers

Implementing serialisation capabilities necessarily involves selecting a number of different vendors to provide different aspects of the end-to-end solution. Many of these purchases are significant and, for many organisations, require a significant amount of rigor to ensure that the most appropriate providers are selected.

To complicate matters further, the supply base for critical serialisation solutions is relatively small and immature and, increasingly, under capacity. Be4ward's experience in selecting and working with many vendors can provide clients with critical insights that they would otherwise not have access to in the procurement process.

Be4ward is often employed by clients to assist in the overall procurement process. Indeed, we can run the entire procurement process if necessary. Our involvement often includes such aspects as:

  • Authoring requirements documents
  • Authoring procurement process documents
  • Analysing vendor responses and responding to their questions
  • Running and/or participating in vendor interview/demonstrations
  • Summarising and presenting recommendations to senior management
Be-Planned: Developing serialisation program and project plans

Serialisation is no different to any other complex, multi-disciplines, multi-organisation program, it needs a bespoke set of plans to ensure optimal delivery in any particular situation. Furthermore, these plans need to be designed to be adaptable to the inevitable challenges and changes that will occur.

Having been involved in many serialisation programs and in various roles, we have the experience in developing and executing serialisation program and project plans.

When planning serialisation activities, our clients gain access to a wealth of planning knowledge that has been tried and tested.

Be-Organised: Putting in place the appropriately skilled teams

Serialisation is a relatively new topic and the pool of people who have the relevant skills and experience in the area are becoming increasingly difficult to find as the demand for their services mushrooms.

One of the initial challenges an organisation faces when embarking on a serialisation journey is to understand what roles they will need to support their program. Be4ward can assist in helping design appropriate teams, define role specifications and assist in the selection process.

Furthermore, Be4ward has access to a broad range of suitably skilled and experience team members and can provide these people to clients either on a full or part time basis. The types of people we typically provide to clients include:

  •  Senior subject matter experts
  • IT architects
  • Business analysts
  • Equipment engineers
  • Validation specialists
  • Program and project managers

If you are struggling to design your team or staff, please do not hesitate to contact us and discuss how we might help.

Be-Validated: Ensuring solutions are appropriately validated or tested

For the majority of companies, applying the appropriate quality standards and processes to a program and their resulting capabilities is critical to success.

Our team has worked with many clients to help define and implement the appropriate approaches to the quality and validation aspects of serialisation, from the on-line inspection of product coding to the validation of enterprise EPCIS solutions.

Be-Financed: Developing serialisation program and project financial estimates

Financial estimates are critical in many organisations to secure the appropriate finance to implement new capabilities.

Serialisation is relatively new to many organisations, so reliable estimates are difficult to develop without the benefit of experience.

The Be4ward team has the experience of multiple projects that they can use to help companies develop thorough and robust estimates.

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BE-AWARE: UNDERSTANDING SERIALISATION LEGISLATION
  • The first challenge for many organisations with regard to serialisation is trying to understand the serialisation legislation across the world, both currently in force and that being developed. Unfortunately, information is not readily available to support this activity. Furthermore, it requires in-depth serialisation knowledge to interpret the often complex and imprecise legislation in a way that is actionable by project teams.
  • Companies need to remember that it is often too late to act on legislation once it has been finalised. It is necessary to make risk based assessments of evolving legislation and act accordingly ahead of time. We use our Target Response approach to facilitate this.
  • Be4ward has an in-depth knowledge of serialisation legislation, both existing and emerging. We also have a great deal of experience in helping clients work with their local regulatory and legal teams to interpret emerging legislation in a timely manner.
  • Be4ward has experience in helping clients define and design support capabilities that address the particular cross-functional and often cross-organisation issues associated with end-to-end serialisation solutions.
BE-AHEAD: USING SERIALISATION CAPABILITY TO DERIVE OTHER BENEFITS
  • Serialisation not only enables companies to meet legislation, but also has a number of other benefits.
  • Many organisations recognise that it is part of a broader product security strategy. The technology can be used within this context to assist with such things as identifying and preventing counterfeiting, fraud and undesirable parallel trade.
  • Other organisations are using the technology to help drive product adherence through the integral use of such things as patient smartphone applications.
  • Serialisation also offers the opportunity to provide product supply chain movement information, regardless of whether a market has track & trace legislation. This in turn opens up many opportunities which can be leveraged by sales and marketing organisations.
  • The Be4ward team has developed product security strategies with clients as well as working on a number of these types of other benefit areas.
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 We share our extensive experience in Serialisation, Artwork, Packaging Supply Chain and Legal Entity in our Experts' Publishing page to help you tackling your projects. Feel free to download any of them and share them with your colleagues. You can also request a hard copy just by filling the form.

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Fill in the form to receive our publishing by mail

Our Case Studies

You can have a sneak peek on some of our projects.

See our Experts

You want more info on those topics? Read the blogs of Andrew and Stephen on Serialisation and Artwork.

Serialisation Publishing

Responding To Serialisation Legislation

Pharmaceutical product serialisation legislation is being developed and approved across the World to help ensure patient safety and prevent reimbursement fraud. Achieveing this across the supply chain is a major and very costly undertaking. Failure to comply with the legislation will mean that companies cannot sell products in the affected markets. This White Paper explains this legislation, its impacts and describes how pharmaceutical companies should tackle the legislation in the most effective way.

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Things we wish we had Known Before Starting a Serialisation Program or Project

While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded many lessons learnt and continues to do so. This booklet explains some of the key things that we wish we had known before embarking on our early projects.

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Top 10 Tips for Developing a Serialisation Strategy

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company such as Regulatory and legislative management and government affairs, Packaging operations, Distribution operations and IT. These capabilities must be implemented effectively in a timely manner to ensure product supply is maintained. The following is a series of tips for developing and implementing your serialisation strategy.

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Artwork Management Publishing

Top 20 Artwork Auditor Tips

We list the top 20 things to consider when auditing pharmaceutical packaging labelling and artwork content creation capabilities. The booklet is designed to help auditing professionals improve their auditing techniques.If you would like a hard copy of this booklet, please send us an email.

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Reducing Packaging Recall Risk

Packaging artwork is a complex but often overlooked aspect in the design of pharmaceutical products. Unfortunately, packaging artwork errors are one of the main causes of product recalls. Many factors are driving companies to increase their product range. This brings with it a corresponding increase in the risk of artwork related recalls and near misses. In this white paper, we draw on our extensive experience of designing, implementing and managing global packaging artwork capabilities to help you understand how to minimise these risks.

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Top 15 Causes of Proofreading Errors

Proofreading is a critical quality control step in the process of ensuring that the packaging labelling and artwork of finished pharmaceutical product is correct. Mistakes in this artwork can put patient safety at risk. Therefore, ensuring that there are adequate processes, people, facilities and tools in place to perform high quality proofreading activities is essential to patient safety. This booklet identifies a number of errors which are typically seen in the design and execution of proofreading capabilities which should be avoided to ensure a quality proofreading result.

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Supply Chain Packaging Publishing

Top 20 Packaging Complexity

Stock Keeping unit (SKU) and packaging component portfolio control is a critical activity for organisations. Ensuring the correct balance between a commercially advantageous portfolio, whilst minimising unnecessary pack and component variants is a challenge faced by many healthcare product companies as they grow their product range and expand into new markets. Therefore ensuring there are decision making processes in the organisation to manage required levels of complexity is a key aspect of effective pack management. This booklet takes the popular Top 20 Tips format to describe key features of a complexity management capability in an easy to digest format.

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Legal Entity Publishing

Managing Product Licence and Packaging Changes Post Merger or Acquisition

We draw on our team's award winning experience in the management of product licence and packaging changes in the aftermath of mergers and acquisitions to explain how to achieve this complex task whilst minimising supply risk and cost.

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Ready to drive the maximum value out of your Packaging Portfolio and Supply Chain?

Many healthcare companies have large or rapidly expanding portfolios of products which are sold in multiple markets. Beyond the United States and the five major European markets, each individual market product volume is often very small, often being only a few packs a day. This presents significant challenges for the supply chain to deliver excellent customer service at reasonable cost, whilst avoiding large stocks of market specific product and packaging components.

Be4ward have helped a number of clients to:

  • Optimize the product portfolio and packaging range offered to their customers.
  • Design optimal packaging supply chains to deliver high degrees of customer service for small order quantities.

Supply Chain Capability Model

Be4ward Capability Model

Specialized in serialisation, the Be4ward team has been working with the world's largest and smallest Pharmaceutical, Biotech and Medical Devices companies with their CMO's to deliver fit for purpose, robust serialization solutions.

With its senior consultants having over 25 years of experience each in the industry, Be4ward has helped clients accross the lifecycle of serialization solution implementation:

  • Developing serialization strategies
  • Ongoing legislation impact assessments
  • Requirement development
  • Independent supplier selection - line systems to enterprise solutions
  • Detailed design
  • Supply chain partner integration design and negotiation
  • Implementation support
  • Validation
  • Support model design and implementation
  • Project and program management

Pharma Serialisation: Be ready for the legislation

Whether you are already on your serialisation journey, or are just embarking on it, Be4ward has a broad range of consulting products to help your program/projects/operations be successful.

Based on our serialisation model, follow the menu on the left to see all you need to implement an healthy serialisation program.

serialisation_scheme Be4ward Serialisation Model

Organisations Membership

As member of these renowned organisations, we ensure to provide services using the latest standards and good practices related to your business.

 

Trusted Experts in Serialisation and Artwork

Sustainable Value

We strive to deliver sustainable value for our clients. In our experience, this is almost always best achieved through a collaborative endeavour between our consultants and your team.

Pharmaceutical Sector

We primarily work with Pharmaceutical industry companies. We have knowledge across the supply chain and therefore can add value working with manufacturers, generic companies, distributors and healthcare providers.The nature of our skills and knowledge mean that we can also work with other highly regulated industries.

Global Scope

The scope of many companies in the Pharmaceutical sector is global. Many of the business issues stem from the fact that these businesses have to operate in many different countries. Our team are drawn from the world’s largest global companies and therefore fully understand these challenges and how to deal with

We are happy to support our clients in any country that does not present a security risk to our team. We have two bases, one in London, UK and the other in Montreal, Canada.

Deep Subject Matter Knowledge and Excellent Consulting Skills

Our team come with a combination of deep subject matter knowledge and excellent consulting skills.

Diverse Engagements

We work on many types of engagement, ranging from strategy development, programme and project initiation through to implementation. Our involvement in these engagements varies depending on the capabilities of the client and how we can add most value. We manage projects for some clients, whilst at the other end of the scale we provide one to one coaching for others.

Collaboration

We believe in a collaborative style of consulting. The majority of our team are drawn from senior management of the global life sciences industry and consulting organisations. This enables them to quickly understand the business context within which our clients are working and discuss and present topics in a way that your senior team can quickly understand.

Independence

We pride ourselves on our independence. Whilst we have knowledge of the supply base in our areas of specialism, we do not have any financial arrangements with other suppliers.

Furthermore, being a niche consulting company, we do not have the desire or capacity to create large projects and sell our clients large numbers of consultants. We focus on providing high value input to help you solve your business problems.

Awards

Our team has won many Awards for their work through out the years. Here are some of the most important received from the industry.

 

 

President's Award
  • Excellence Award for France Coding Project
  • Innovation - Global Pack Management Project
  • Excellence Award for Global Pack Management Upgrade
  • Performance Improvement - Corporate Legal Entity Integration
British Quality Foundation
  • Four Star Quality Award - Pack Management Service Center Operation
Food & Drug Packaging
  • Drug Packer of the year 2004
Starpack Gold Star Award
  • Late Pack Customisation

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London, UK |48 Warwick Street, London, W1B 5AW
Toll Free: 0800 098 8795
Phone: 0203 318 0936
Fax: 0203 318 0932

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Fax: 1 (514) 800 2107

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Be4ward provides specialist consulting services to the Pharmaceutical and other highly regulated industries.

We deliver value to our clients thorough a combination of deep subject matter expertise and excellent consulting skills.

Whilst we have a thorough understanding of the supply base in our areas of focus, we pride ourselves on providing entirely independent advice to our clients.

 

 

Our Areas of Focus
  • Product coding, serialization and anti-counterfeiting capabilities
  • Packaging and artwork design capabilities
  • Post merger legal or acquisition brand integration
  • Secondary packaging and distribution supply chain design
  • Product complexity management, late customization and postponement
  • Pharmaceutical product launch and portfolio management
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 GlobeBe4ward provides specialist consulting assistance to clients across the globe. We are happy to work at your location(s), remotely or in a combination of the two.

 

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Packaging Artwork Document Verfication
and Proofreader Training Course

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You have successfully purchased your course.

The course is in the final stages of completion and will be ready in a few weeks.

We will contact you in the next few days by email to update you on our progress.

In the meantime, if you have any questions, please contact us at enquiries@be4ward.com.

Thanks again from the team at Be4ward.

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Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

Foreword by Steve Richmond, Head of Global Packaging, AstraZeneca

“If you are looking to improve the performance of your company’s artwork capabilities then this book is a must read. It captures the authors’ vast experience in turning around the artwork operations of healthcare companies and provides a unique and valuable resource for anyone involved in the area.”

– Steve Richmond
Head of Global Packaging, AstraZeneca
Autors

Stephen McIndoe and Andrew Love have a passion for improving patient safety whilst at the same time helping the healthcare industry to deliver vital medicines to patients in the most effective way. They are world experts in developing excellent pharmaceutical and healthcare packaging labelling and artwork capabilities and have been instrumental in transforming a number of companies’ artwork capabilities into world-class operations.

The knowledge and expertise contained in this book will help you to understand and deliver the right mix of packaging artwork capabilities for your organisation, in a shorter period of time, at lower cost and with significantly less risk. Inside you will find in-depth discussion on the following topics:
• The importance of artwork capabilities in delivering today’s business strategy. • The causes of artwork errors. • Detailed discussion on each of the elements which go to make up the overall artwork capability, including: business processes; education, training and competence assessment; organisation design; technology and outsourcing. • Making sustainable improvements happen. • Future developments.

Now available at Amazon.com and Amazon.co.uk.

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We pride ourselves on a unique combination of deep subject matter knowledge and excellent management consulting capability.

Furthermore, our dynamic global team strive to deliver real value to our clients whilst having fun and balancing their home and work-life needs.

Our clients are based around the world, although the majority of our work centers around Europe and North America. We therefore seek team members from these areas.

The highly sought after nature of our skills mean that we can reward our team well for the work they do, whether as members of staff or as associates.

To find out more please contact us stating your interest in employment with us.

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Without prejudice to the generality of the foregoing paragraph, Be4ward does not warrant that:

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Nothing on this website constitutes, or is meant to constitute, advice of any kind.

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Be4ward will not be liable to you (whether under the law of contact, the law of torts or otherwise) in relation to the contents of, or use of, or otherwise in connection with, this website:

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These limitations of liability apply even if Be4ward has been expressly advised of the potential loss.

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By using this website, you agree that the exclusions and limitations of liability set out in this website disclaimer are reasonable.

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You accept that, as a limited liability entity, Be4ward has an interest in limiting the personal liability of its officers and employees. You agree that you will not bring any claim personally against Be4ward’s officers or employees in respect of any losses you suffer in connection with the website.

Without prejudice to the foregoing paragraph, you agree that the limitations of warranties and liability set out in this website disclaimer will protect Be4ward’s officers, employees, agents, subsidiaries, successors, assigns and sub-contractors as well as Be4ward.

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If any provision of this website disclaimer is, or is found to be, unenforceable under applicable law, that will not affect the enforceability of the other provisions of this website disclaimer.

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At Be4ward Ltd, we are committed to maintaining the trust and confidence of our visitors to our website and subscribers to our newsletter and other email marketing campaigns.  Here you will find information on how we treat any data that we collect from such people.

Information We Collect

Be4ward collects and processes a small amount of personal information to allow us to communicate with current and potential clients, suppliers and partners. This information typically includes such things as name, email address, telephone number and place of business.

How your Personal Data is Used

Where you submit your personal information to us, it will only be used by us for:

•the purposes for which it was provided by you and any reasonably incidental purposes including providing you with the information that you request from us;
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Be4ward Ltd undertakes not to sell or rent to any third party whatsoever any personally identifiable information about you.

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We process personal information on the grounds of Legitimate Interest, for certain legitimate business purposes, which include some or all of the following:

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Whenever we process data for these purposes we will ensure that we always keep your Personal Data rights in high regard and take account of these rights. We will make it clear when we collect personal information and will explain what we intend to do with it.

When someone visits www.be4ward.com, www.andrewrlove.com and www.stephenmcindoe.com we use a third-party service, Google Analytics, to collect standard internet log information and details of visitor behaviour patterns. You can view Google Analytics privacy policy here. This information is only processed in a way which does not identify anyone. We do not make, and do not allow Google to make, any attempt to find out the identities of those visiting our website.

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We use a third-party website software application, WordPress (and its plug-in application Jetpack), to help us understand what topics are of interest to you when you download content from our website.  You can view WordPress’ policy here.

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If Be4ward act as processor or controller of your personal data, Be4ward acknowledge that the individual has:

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If you would like to exercise your Individual Rights, email your request to enquiries@be4ward.com. You also have the right to lodge a complaint with a supervisory authority

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We keep our privacy notice under regular review. This privacy notice was last updated on 18th May 2018. To contact us regarding this Privacy Policy, please email enquiries@be4ward.com.

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Telephone: Toll Free 0800 098 8795
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