Drug Registration & Post-Authorisation

Our experienced consultants are committed to provide all support you may need in the following activities:

  • Regulatory advice and assistance for setting up meetings with the French Authorities
  • Advice and writing of dossiers (MAA, CTA, CMC variations, labelling variations (DMI), renewals, OTC switch dossier and drug non-compliant use reports)
  • Publishing and submission via CESP
  • Undertaking local Blue Box applications
  • Early-access programs (ATU): Advice and dossier preparation
  • Packaging review
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