Smartpharm is active in SEE (South Eastern Europe) and CIS (Commonwealth of Independent States) regions. A characteristic of all these markets is that although they more or less closely follow the EU requirements for dossier contents, each country has its specifics and all of them require national procedures.

Our regulatory staff is locally present in all the territories and has extensive hands-on experience with registration of products for both innovative and generic pharma companies. By ensuring constant local presence, we can be sure that we will receive new product registrations in shortest time possible.

The only thing that we require from our partners is a EU CTD type dossier. We handle all pre-submission activities, submit dossiers locally, convey responses to defficiencies to the authorities and handle variations and registration renewals.