Act as Marketing Authorization Holder (MAH ou local representative) in Japan and handle all local regulatory, quality and pharmacovigilance activities for the Ge/Ga-68 Generator (the product). Coordinate the registration…
process (New Drug Application “NDA”) of the product in Japan in compliance with MHLW (Ministry of Health, Labour and Welfare) and PMDA (Pharmaceuticals and Medical Devices Agency) regulations and standards and maintain the registration. Import and release the product in Japan.
Act as Marketing Authorization Holder (MAH ou local representative) in Japan and handle all local regulatory, quality and pharmacovigilance activities for the Ge/Ga-68 Generator (the product). Coordinate the registration