Active pharmaceutical ingredient (API) is any substance or mixture of substances intended to be used in the manufacture of drug products.
For successful organization and support of API registration, we provide the following services:
- Full-range services in registration of API intended to be used in production of drug products.
- Full-range services in registration of API not included into the formula of drug products.
- Collection of documents to obtain the Russian GMP certificate for the manufacturer of pharmaceutical substances.
- Modifications of API Dossiers (Master Files) and API Normative Document
The registration procedure is described as per Federal Law No. 61 «On Drug Circulation» dated
Registration workflow
Obtaining a Russian GMP certificate for the manufacturer of pharmaceutical substances
- Development of a 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 API 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 API according to Federal Law No. 61.
- Registration on the website of the ministry of Health, compilation of electronic application.
Examination of API quality
- Preliminary simulation of quality control methods for a pharmaceutical substance
- Submission of API Dossier to the Ministry of Health of the Russian Federation
- Support in registration process, obtainment of decision on registration of API.