Drug products are dosage forms used for prevention, diagnostics, and treatment of a disease.
For successful organization and support of drug product registration, we provide the following services:
- Collection of documents to obtain a Russian GMP certificate for the manufacturer of pharmaceutical substances.
- Collection of documents to obtain approval for conducting clinical trials.
- Arrangement and monitoring of pre-clinical trials of a drug product.
- Arrangement and monitoring of clinical trials of a drug product for its registration in the territory of the RF.
- Registration of drug products.
- Registration of generics as well as original drugs in Russia.
- Registration of new developments in the case, changes in dossier.
- Confirmation procedure of drug product registration
- Re-registration of a drug product.
Registration workflow
Obtainment of the Russian GMP certificate for the manufacturer of pharmaceutical substances
- Development of Site Master File and its submission to the regulatory authority.
- Getting approval for the factory inspection by the experts of the State Institute of Drugs and Good Practices.
- Inspection and receipt of results on conformity of the drug product manufacturer to the specified requirements of GMP.
Pre-examination of the dossier (Master File)
- Preliminary analysis of the dossier’s conformity, consultation for the client
- Translation and notary certification of documents.
- Adjustment of the Registration Dossier (MF) and Normative Documentation on the drug product according to Federal Law No. 61.
- Determination if pre-clinical and clinical trials shall be conducted.
Pre-clinical trials
- Selection of clinical sites for pre-clinical trials.
- Development of clinical trial protocols
- Arrangement and monitoring of pre-clinical trials of a drug product.
- Statistical processing of data and final report on pre-clinical trials.
Clinical trials
- Development and agreement of document package required to obtain approval to conduct the clinical trials.
- Selection of clinical sites for clinical trials.
- Getting approval to conduct the clinical trials.
- Conduct of clinical trials, statistical processing of data, reporting, notification of the Ministry of Health on completion of clinical trials.
- Expertise of the drug product benefit-risk by the authorised body (Federal State Budgetary Institution Scientific Centre for Expertise of Medical Products)
Submission of Product Dossier to the Ministry of Health
- Finalization of the Registration Dossier (MF) of the drug product according to Federal Law No. 61.
- Registration on the website of the Ministry of Health, compilation and submission of electronic dossier.
- Submission of Product Dossier to the Ministry of Health.
- Examination of the quality of the drug product and expertise of the benefit-risk ratio of the drug product for medical use.
- Obtaining Marketing Authorisation for the drug product.