regulatory affairs
Product registration service includes continuous tracking of legal requirements, exceptional knowledge of regulatory processes and quality communication with authorized institutions and agencies.
As a part of process of registration files preparation and obtaining marketing authorization our team offers you the following services:
Assessment of registration documents
Obtaining a Marketing Authorization for human medicines
Renewing a Marketing Authorization for human medicines
Transferring a Marketing Authorization for human medicines to another holder
Variations (amendments) of a Marketing Authorization
Pharmacovigilance services
Tracking regulations of the Republic of Serbia related to this area and providing timely information to the client
Adequate storing of all data and documentation
For medicinal devices:
Registration in the Register of Medical Devices
Variations of registrations
Re-Registration in the Register of Medical Devices