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