Clinical Study Design Preparation
Medical Writing
Consulting and Regulatory Support
Drug Safety and Pharmacovigilance
Project Management and Monitoring
Data Management and Biostatistics
Marketing Authorization
GMP Inspection Support
Clinical Supply Services and Logistics
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Marketing Authorization

OCT is your trusted marketing authorization partner for clinical trials in Eastern Europe.

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

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 maximum delivery of 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, and 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

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