Specific Services for France

BlueReg France

A “France” dedicated team of highly qualified consultants:

 

  • With significant hands-on industry experience and broad expertise in national Regulatory Affairs, Quality management, Market Access and Pharmacovigilance,
  • Holding a large & flexible skill set, ranging from strategic consulting to operational execution, as well as leading and managing projects.

 

This team provides expert advice as well as hands-on operational activities and works with many clients, from biotech start-ups to large pharma companies looking for local expertise or specific services for France and for any types of projects even the most sensitive and complex ones.

blueregimg2_03

Among our latest missions

  • Review and submission of local promotional materials for pharmaceutical products and medical devices
  • Preparation of cohort ATU (early access) applications for an Orphan Drug
  • Handling of all local regulatory activities for a portfolio of pharmaceutical products
  • Supporting a US client in obtaining an “Exploitant” status from ANSM for its newly created affiliate in France. This included providing strategic advice to the client, setting up a specific Quality Management System and preparing the “Exploitant” application filed to ANSM.”
EARLY-ACCESS-PROGRAMME

Discover our last white Paper

Learn more