Pharmaceutical Regulatory Affairs in Russia

We provide the following services for registration of medicines in Russia, EAEU, CIS + Ukraine, Georgia, Mongolia:

We provide the following services for registration of medicines in Russia, EAEU, CIS + Ukraine, Georgia, Mongolia:

1. Preparation of documents of the registration dossier for medicines and / or pharmaceutical substances for submission for registration/re-registration/amendments according to the national procedure or the procedure of the EAEU (OTD format with xml-coding);

2. Formation of a package of documents for registration/re-registration of the maximum selling price of the manufacturer for drugs included in the list of VED;

3. Development of instructions for medical use (IMP) and / or the General characteristics of the drug (OCLP) in accordance with national requirements or the requirements of the EAEU;

4. Development of regulatory documentation (ND) for drugs and / or pharmaceutical substances;

5. Organization of the comparative dissolution kinetics test (TSCR);

6. Translation of specialized medical, pharmaceutical and chemical documentation;

7. Preparation of reviews of scientific papers on the results of preclinical and clinical trials of medicines;

8. Preparation of documents for obtaining permission to import a specific batch of unregistered medicines for the development, research, control of safety, quality and effectiveness, implementation of state registration, inclusion of a pharmaceutical substance in the state register and quality control.

You need to know
Read useful information on the legal framework of the Russian Federation and our activities in the field of scientific and practical conferences and congresses.
Useful information
Useful information
Legal basis of clinical trials of drugs in the Russian Federation.
Our event
Our event
Plan of scientific and practical conferences and congresses organized by Medical Development Agency in 2019-2020.
Our team
Medical Development Agency specialists are not just experienced managers who have a solid background of knowledge, skills and successfully implemented projects. It is also a friendly, cohesive team that ensures a high level of efficiency of our work and the competitiveness of the company in the market.
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