Affaires réglementaires

Registration activities

  • Writing of MA applications (Modules 1 to 5) in European (DCP, MRP, CP) or national procedures
  • SmPC preparation, patient information leaflet, labeling
  • Realization of readability tests
  • Writing the Environmental Risk Assessment (ERA)
  • Drafting of the Risk Management Plan (RMP)
  • Risk Analysis Writing for Elemental Impurities (ICH Q3D)
  • CEP file writing and Active Substance Master File (ASMF)
  • eCTD formatting of new or old folders (baseline)
  • Electronic submission on behalf of clients (CESP portals, Web Client)
  • Follow-up of procedures and exchanges with the health authorities
    • on behalf of our customers (handling of MA)
    • as a contact person authorized by our clients

Regulatory maintenance activities

  • Administrative Variations, Quality, Non Clinical and Clinical
  • Requests for changes to information (DMI)
  • Extension of therapeutic indications
  • MA renewal
  • Determination of the positioning of variations
  • Submission strategy (grouping, worksharing)
  • Request for exemption (sunset clause waiver)
  • Handling and transfer of MA, change of marketing company (“Exploitant”)

Experience special drugs

  • Herbal products
  • Medical gases


with our partner
  • Consulting and writing services of regulatory dossiers in accordance with new EU regulation
  • Files Quality, Safety and Efficacy (UE format)
  • Administrative procedures
  • Follow-up and exchanges with Authorities
19, rue Georges Clemenceau
78000 Versailles - France
Tél. +33 (0)1 42 86 86 00