Partnership to set up a European Regulatory footprint

The client 

A clinical-stage biotechnology company that is working to become a fully integrated pharmaceutical company specializes 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. 

ProductLife Group (PLG) 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: in France, Germany, Italy, Spain, and the United Kingdom, Denmark, Sweden, Norway, Finland, Ireland, Austria and Switzerland. 

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.  

• To start with, PLG 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.  
• Then 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. PLG has appointed one project manager and one regulatory affairs project lead as the key contacts to receive all requests from headquarters and the affiliates. 
• PLG 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.  
• Specific country support for QA & RA, in Germany, Italy and UK 

The client is preparing its affiliates to become able to handle local regulatory requirements and manage the nuances of each market was a challenge. 

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 (3) the project was enlarged to new activities (QA and local RA).