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.


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.”

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