Pharmaceutical Regulatory Affairs in Russia
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.
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