Regapharm - GMP certification in Russia and European Union

We improve the competitiveness of your business not only at the Russian market, but in the international field too

We help Russian companies to obtain a GMP certificate from the European Union for the introduction of Russian medicines to international markets. This GMP Certificate is issued by Germany, which automatically makes it effective for any other EU country. Thus, you can export your medicines to any EU country.
We help foreign companies to obtain a Russian GMP certificate for the launch of imported medicines in the Russian pharmaceutical market.
We provide a full complex consultation on the issues of inspection of manufacturing sites by Russian and European GMP licensing authorities.

"Regapharm" offers you a comprehensive approach and effective solution of the problem of registration of medicinal products

GMP certification is conducted in several stages

Analysis of administrative documents and the dossier of the production site
Compiling of a dossier and submitting it to the appropriate Licensing Authority in Russia or in Europe.
Coordination of plant inspection dates.
Carrying out inspection of the manufacturer's factory by the licensing authorities of the Russian Federation or Germany.
Obtaining an inspection report on the plant and issue a GMP Certificate.
The timing of the inspection of the manufacturer's factory and obtaining of the GMP certificate depends on the country issuing GMP certificate and each specific situation.

List of documents required for registration of API

List of documents required for obtaining Russian GMP certificate by a foreign producer

Federal Law от 12.04.2010 № 61-ФЗ «Drug circulation»

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