Edwige Mével, Pharm D

Regulatory Affairs 


Edwige has more than 20 years of experience in Regulatory Affairs in the therapeutic areas of oncology, thrombosis and dermatology for big pharma companies and Biotech (Novartis, Sanofi-aventis, Galderma,  Merck and Innate Pharma). She brings her broad international experience in all relevant regulatory “tools” for the development area including paediatric development, orphan drug designation, DSUR, CTA/IND management, crisis management for urgent safety alerts, CMC expertise, and most importantly involvement in global Health Authority Interactions (FDA, EMA, PMDA, SFDA). She also gained experience in CTD submission in oncology and life-cycle management to support marketed products.