Russian/EEU GMP

According to regulation in force all foreign drug manufactures presenting at Russian market should obtain Russian GMP certificate. We will give you detailed consultation regarding the procedure and requirements, make preliminary assessment of site master-file (SMF) and represent your interests in Ministry of Industry and Trade of Russian Federation.

In general, GMP requirements of Ministry of Industry and Trade are harmonized with international ones but there are some peculiarities in the procedure itself: the application form and the dossier should be performed in Russian, SMF should contain all appropriate information and all documents should be authorized properly. Cooperation with our company will save your time and money as we have accumulated good experience in organizing GMP inspection for foreign drug manufactures.