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Pre GMP Audit in Russia

In case you are afraid of a Russian GMP audit, our Russian CPC experts can support you in order to achieve the RU GMP certificate during the first audit date. Due to our more than 20 years Russia experience and regulatory network we can guarantee the success.

Did not pass the RU GMP audit?
With our GMP experts and regulatory network, we would be able to support you closing the gaps and achieving the GMP audit quickly.

Russian GMP Certificate

As a decree from the Ministry of Industry and Trade of Russia, from 2016, any Russian and international manufacturer of finished products is required to have a Russian GMP Certificate in order to supply to the Russian market. This means that both Russian and foreign production sites have to be certified, also when the company is already based in Russia and/or has production sites in other countries.  Without this certificate it is impossible to register new pharmaceutical products or to re-register the ones that are already in the market.

The process to get the certification is not easy to do and can take some months as documents should be submitted, audits and inspections have to take place and a resolution has to be made; in addition to the preparation to all of this.

The validity of this certificate will be for 3 years and the costs that have to be paid consist of cost of application and all other related expenses.

Certification consists of several stages which have to be fulfilled systematically and correctly in order to be able to continue the process. This is why, preparation for the audits that will take place is key to succeed.

Featured image: Photo by Pujalin on Unsplash


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