"Regapharm" offers you a comprehensive approach and effective solution of the problem of registration of API
The registration procedure is described in accordance with the Federal Law No. 61 "On the Circulation of Pharmaceuticals" with all amendments including those entered into force on January 1, 2016
Preliminary review (analysis) of the profile
- Preliminary review of the profile, consultation for customers
- Check of submitted documents for completeness and compliance with registration agency criteria
- Calculation of registration costs, making a decision with the customer
Obtaining the GMP-certificate in compliance with the Russian standards for API manufacturers
- Preparation of the manufacturing site profile and its submission to the Russian Federation Ministry of Industry and Trade
- Obtaining the plant inspection permit, with the inspection to be carried out by experts from the State Institute of Drugs and Good Practices
- Holding the inspection and obtaining the GMP standards compliance report for ingredient manufacturers
- Full support of the process on each stage
To obtain a positive GMP standards compliance report for an ingredient manufacturer, and to thereby receive a GMP certificate, it is extremely important to have a properly composed manufacturing site profile, correctly designed and approved, on the first try.
Submission of the API profile to the Ministry of Healthcare
- Preparation and profile completion according to FL-61
- Registration on the Russian Federation Ministry of Healthcare site, and creation and submission of document e-copies (application for service in electronic form)
- Development of the API registration profile and certificate
- Preliminary presentation of quality control methods for the active pharmaceutical ingredient
- Submission of the API profile to the Russian Federation Ministry of Healthcare
- Support of the registration process, decision receipt on active pharmaceutical ingredient registration
List of documents required for registration of API
List of documents required for obtaining Russian GMP certificate by a foreign producer
Federal Law от 12.04.2010 № 61-ФЗ «Drug circulation»
To receive a consultation on API registration services in Russia, please use the form below.