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C A S E S T U D Y

Expertise across Markets Sets Biotech Company on the Right Course

The ClientA clinical-stage biotechnology company that is working to become a fully integrated pharmaceutical company specialises in the discovery and development of small-molecule medicines with novel modes of action. The company recently established affiliate offices in France, Germany, Italy, Spain, and the United Kingdom in preparation for its first product launch.

Project ScopeProductLife Group began working with the client in September 2019—initially to carry out regulatory intelligence covering local requirements for launching, distributing, and promoting a product in the big European markets. The second objective was to provide on-demand consulting in the areas of regulatory affairs, quality assurance, pharmacovigilance, promotional and legal compliance, and market access. The third, larger project involved preparing a compliance framework in each of the five affiliate offices, developing standard operating procedures, and creating working-practice documents and guidance documents on their behalf in order to ensure clear and detailed processes were in place and to comply with local up-to-date regulations.

ProductLife Group has appointed one project manager and one regulatory affairs project lead as the key contacts to receive all requests from headquarters and the affiliates. The project lead coordinates all of the local experts in each country by organising projects and feedback from regulatory, quality, and pharmacovigilance in each market. The project lead also coordinates with the ProductLife Group project manager, who ensures proper governance oversight of the project.

ProductLife Group Supports Clinical-Stage Client with First Product Launch

ProductLife Group specialises in helping international life sciences organisations more effectively get their products and therapies to market by providing those clients with functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing.

Performing successfully for more than 25 years, ProductLife Group has an established global presence in Europe, the Middle East, Asia Pacific, Africa, Latin America, and North America. We deliver services via an innovative, platform-and-hub operating model, enabling our clients to achieve continuous improvement, increased quality, enhanced performance, reduced risk, better compliance, and overall cost benefit. That approach, combined with our collaborative, partnership-oriented culture, empowers life sciences organisations to realise the commercial potential of their own international operations.

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ChallengesThe client is striving to become a larger pharmaceutical company, but preparing its affiliates to become able to handle local regulatory requirements and manage the nuances of each market was a challenge. ProductLife Group has been providing support for the affiliates from the outset.

Since the project began in September 2019, much has changed—and continues to change. Of greatest importance to the client are (1) to have flexibility and (2) to be sure that the right expert is working with the right affiliate on a peer-to-peer level, and therefore, having a partner with expertise across the multiple areas of regulatory affairs, promotional and legal compliance, regulatory operations, quality assurance, pharmacovigilance, market access, and medical information is a priority.

Project DescriptionTo start with, the ProductLife Group team worked with the client’s headquarters to support the company in expanding its footprint into key markets, to manage the project scope and deliverables, and to determine the type of support affiliates would require. To prepare the company, ProductLife Group:

• Contributed to the strategy for product launch, distribution, and promotion in each market by providing key market information, relevant local authority websites, references, and insights on regulatory requirements in each country.

• Continued answering specific questions and preparing guidance documents for the affiliates when it came to regulatory affairs, promotional and legal compliance, regulatory operations, quality assurance, pharmacovigilance, market access, and medical information topics.

• Put in place standard operating procedures and guidances to help affiliates have detailed processes in place and be in compliance with local requirements.

• Supported the client with local-market-access expertise.

Customer BenefitsProductLife Group’s affiliate outsourcing model (AOM), although designed primarily to manage maintenance activities, can be easily adapted to manage the needs of a client moving from the clinical stage to marketing authorisation and launch. In addition to being a source of on-the-ground affiliate expertise in multiple markets, AOM makes sure the client has one partner coordinating all activities in Europe and overseeing governance of the project. ProductLife Group’s team of experts provides the new affiliate offices with the resources they need—in the right place at the right time—and responds to questions the affiliates may have, thereby ensuring business continuity for the organisation as it works to grow its operations.

ProductLife Group’s partnering flexibility as well as the firm’s market and functional depth gives the client the support it needs for success in the endeavour. And having a single point of contact through the project lead vastly simplifies the process of managing projects and meeting affiliates’ needs.

ProductLife Group Success FactorsThe project began with regulatory intelligence support and has grown to include broader, project support. As the client continues expanding into new markets and as new products come through the pipeline, ProductLife Group has both the market coverage and functional expertise across the areas of regulatory affairs, promotional and legal compliance, regulatory operations, quality assurance, pharmacovigilance, market access, and medical information to support the client’s growth. In addition, thanks to its long-term proven experience in governance and overall management of large outsourcing projects, ProductLife Group has ensured a streamlined and efficient partnership between the client’s head office and the various teams.