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
