Main benefits of outsourcing "Exploitant" status : Reminder : French regulatory authorities require having an « Exploitant » authorized and established in France to manage an early access program in France or a Marketing authorization. Immediate activation of French Affiliate…
Download the 5 must-know 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
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, writing…
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 regulations that…
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.