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Specific Services for France - BlueReg Group

Specific Services for France

BlueReg Group Specific Services for France

BlueReg France

A dedicated team of highly qualified consultants to provide services in France:

 

  • With significant hands-on industry experience and broad expertise in national Regulatory Affairs, Quality management, Market Access and Pharmacovigilance.
  • Having varied and flexible skills, 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. The team works with many clients, from biotech start-ups to large pharma companies looking for local expertise or specific services for France. The team have a highly successful track record of delivering all projects, from the simple to the complex.

Bluereg french consultant

Strategic advice & regulatory analysis

Drug Registration & Post-Authorisation

Promotional & educational material review (Drugs and Medical devices)

Early Access programmes (ATU)

Quality System and Audit

Product Quality Review

Market Access France

Pharmacovigilance

Our latest engagements

  • 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.”