• Regulatory affairs

OUR EXPERTISE

ADVISE EXPERTISE

Advise and regulatory strategy
Technical and regulatory audit of dossiers
Representation to regulatory agencies
Support for scientific advice meetings

MAINTENANCE

Variations (IA, IB, II)
Renewals
Answer to questions from the Authorities

MA DOSSIER

IMPD/IND writing
MA dossier writing (modules 1 to 5)
CMC (module 3) expertise
Centralized, decentralized, mutual recognition, national procedures
CTD / e-CTD / NeeS

SUBMISSION

Management of procedures with Authorities
Submission (CESP) and follow-up of registration procedures