Our team offers a full range of high-quality services for marketing authorization in Russia for both domestic and foreign sponsors.

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While it is relatively easy to go through all the international standards and guidelines on clinical trials and determine what is allowed and what is not, our value as specialists is to adapt to the existing restrictions with the maximum delivery on the goals and quality expectations of our clients.

Natalya Eliseeva Regulatory Manager

Our support includes:

• Preparation of a document dossier: administrative documents, description of pharmaceutical properties, technological data, information about the pre-clinical and clinical studies of the drug
• Submission of the dossier to the Ministry of Health of the Russian Federation.
• Qualified support and communication with regulatory authorities, processing of official enquiries and letters
• Obtaining a marketing authorization certificate