Drug Registration & Post-Authorisation

Our experienced consultants are committed to provide any ad-hoc assistance you may need in any of the following:

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

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