Documents

  Download the 5 must-knows for US Biotechs looking to run Early Access Programs in France:   Regulatory Constraints – The Exploitant Financial and Resources Constraints Administrative and Management Constraints New Regulations in 2021 French fast evolving regulations    

  You are not familiar with the fast evolving Early Access French regulation and Exploitant Status ?   Download the list of requirements for the Early Access program.    

  Download the 5 common mistakes companies face when navigating French Early Access Programs:   Planning from the early stage Not enough European/French resources available Partner with a “low-cost” Exploitant Early Access Programs – Differences in Regulation and Implementation Changing…

  An American pharmaceutical company starting to build its European affiliates entrusted PharmaBlue with the responsibility of submitting, obtaining, and implementing a French Early Access Program for its orphan drug. PharmaBlue support them for the whole process of submission (advice,…