Everything to know about exploitant status in France

16 June 2023

Non classé

About the "Exploitant" status   French regulatory authorities require having an « Exploitant » authorized and established in France to manage an early access program in France or a Marketing authorization.   At the European level, there are three separate…

Learn more

Benefits of using a third party Exploitant to run early access programs in France and more

12 June 2023

Non classé

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…

Learn more

How to take advantage of early access programs for your innovative treatments in France?

2 May 2023

Blog Posts

Known as Expanded Access Programs in the US, early access programs (EAP) allow access to medicines for certain patients before marketing authorization.   The French early access program, authorization for temporary usage or temporary authorization (“autorisation temporaire d’utilisation” - ATU),…

Learn more

9 Must-knows for US biotechs looking to enter the EU Market

26 April 2023

Blog Posts

Late-stage American biopharmaceutical companies in late-stage development for their product are logically interested in the European market, and we clearly see a trend of companies looking to expand in Europe by themselves rather than partnering with an establishment based there.…

Learn more