Russia Regulatory Affairs

The best company for registration of Medicines\Drugs in Russian Federation — Medregconsult.com

The best company for registration of Medicines\Drugs in Russian Federation — Medregconsult.com
1. Registration of Medicines in Russian Federation

For to be able to sell your products in Russian Federation it should be registered by the Ministry of Health.
Working with us is the shortest and safe way to get Marketing Authorization.
Overview of Procedure

Before registration
Local Clinical Trial

At least one clinical trial should be performed in Russia. It could be exceptional cases where it is not mandatory to perform it (Generics presented like gases, aqueous solutions etc.)
We could help to your company to define the best CT strategy and conduct the study.
GMP inspection

Before submission applicant should receive RU GMP certificate for all manufacturing sites participated in production of finished products.
We could take this on our shoulders: to make all arrangement, prepare plant to audit, organize and follow up inspection and get final decision. (please see more here)

Registration

Based on Guidelines procedure takes app. 12 months.
Dossier should be provided in Russian language.
Manufacturer should provide samples of products and reference standards.

After registration
After approval we could support you in the following activities:

Registration of prices included in EDL (essential drug list)
Support with regulatory Life cycle management of products (variations\renewals)
Support with PV activities.

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