Expertise in Regulatory Affairs

Regulatory Affairs is the interface between pharmaceutical manufacturers and national and international regulatory authorities with respect to authorization files. The multidisciplinary team of Regulatory Affairs specialists provide an integrated support for file application and authorization from the stage of pharmaceutical development and clinical stages, up to the post-marketing stages (variations, updating of authorization dossiers), by dealing with:

• documentation for the authorization of  medicinal products for human and veterinary use, cosmetics, food supplements, medical devices for the markets of Romania, for the EU, US, Canada, Russia and CIS states, as well as for Africa, Asia, Latin America;
• maintaining current Marketing Authorizations through variations and renewals;
• authorization by national procedures or by decentralized procedure (DCP), mutual recognition (MRP);
• the documentation for obtaining the Certificate of Suitability for API in line with the European Pharmacopoeia and its renewal;
• ASMF (Active Substance Master File)/DMF (Drug Master File) Type II;
• specific in-licensing and out-licensing documentation.