LEGISLATION AND REGULATORY
The role of regulatory affairs is vital and indispensable in putting a certain product on the highly regulated market, such as pharmaceuticals.
Our legislation and RA team is made of regulatory professionals who ensure regulatory compliance. They are highly educated and regularly up to date with the national and EU legislation.
We may offer the Regulatory Affairs services, performed by our RA department, which include all the activities proscribed and regulated by the Medicines and Medical Devices Agency of Serbia, such as: registration of product, maintenance of marketing authorization, variations, pharmacovigilance, approval of advertising material etc.