"Regapharm" offers you a comprehensive approach and effective solution of the problem of registration of medicinal products
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
Pre-expertise of the dossier
- Initial examination of the dossier, the customer consultation
- Identifying the need for pre-clinical (DKI) and clinical (CT) studies in accordance with the Federal Law of 12.04.2010 number 61-FZ "On the Circulation of Medicines" as amended on 29/12/2015
- Evaluation of the completeness of the submitted materials and their compliance with the requirements of registration authorities
- Calculating the cost of registration, coordination with the customer
Pre-clinical studies of a drug – in the case of need, the determination of step I.
- Selection of scientific centers for pre-clinical drug trials
- Preparing the design if pre-clinical drug study
- Execution of pre-clinical trial
- Preparing Statistical report of trial and Final Pre-clinical study report
Presentation to Ministry of Health results of high quality pre-clinical studies, which were correctly designed and executed is an essential tool for obtaining permission to conduct a Clinical Study.
Conducting the Clinical Study of the drug - if necessary, determined in step I.
- Development and approval of the package of documents required to obtain permission to conduct the Clinical Study, selection of clinical sites
- Obtaining permission for Clinical Study
- Conduct of Clinical Study, processing of statistical data, preparation of the report, the Ministry of Health notification on the completion of the Clinical Study
- Examination of the expected benefits and possible risk ratio of the use of the drug by the authorized body (FGBU NC ESMP)
Submission of the dossier of a medicinal product to the Ministry of Health
- Compilation and completion of the dossier in accordance with Federal Law - 61
- Registration on the Ministry of Health website, the formation of the electronic application
- Submission of the dossier to the Ministry of Health
Examination of the quality of the drug and the examination of the relationship of the expected benefits and possible risks of the use of the drug for medicinal use
Conducted by the State authorized body (FGBU NC ESMP)
Completion of the registration process, introduction of the state register
- Obtaining Registration Certificates and delivering them to the Customer
List of documents required for registration of pharmaceutical products
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 drug registration services in Russia, please use the form below.