Marketing authorization of pharmaceutical products and substances
Our services for organizing and supporting registration of pharmaceutical products
Registering original and generic pharmaceutical products
Registering amendments to the dossier
PP manufacturer, market authorization holder, quality control methods, excipients, expansion of indications, changes to safety profile, addition of a manufacturing site, etc.
Preparing the document package
To obtain a permit for clinical trials of the pharmaceutical product, obtaining a permit to conduct clinical trials
Arranging and monitoring clinical trials of the pharmaceutical product
For the its registration in the Russian Federation, and as part of international multi-centre clinical trials
Arranging and monitoring preclinical studies of the pharmaceutical product
PP registration confirmation procedure
Preparing and submitting periodic safety reports for the pharmaceutical product
Preparing and submitting periodic safety reports for the pharmaceutical product
Confirming pharmaceutical product registration
We offer a comprehensive solution for registering pharmaceutical products
The registration procedure is described in accordance with Federal Law No. 61, On the Circulation of Pharmaceutical Products, including all amendments that had entered into force as of January 1, 2016
I
Preliminary evaluation of dossier
- Perform an initial evaluation of the dossier and provide client consultation
- Calculate the cost of registration and come to an agreement with the client
II
Preclinical studies of the pharmaceutical product if applicable, as determined in Stage I
III
Clinical trials of the pharmaceutical product if applicable, as determined in Stage I
- Prepare the document package to obtain a permit for clinical trials of the pharmaceutical product, selection of clinical facilities
- Obtain a permit for clinical trials
- Conduct clinical trials, processing statistical data, preparing the report, notifying the Ministry of Health upon completion of the clinical studies
- Evaluation of the expected benefit/risk ratio for the use of the pharmaceutical product conducted by the competent authority (Federal Scientific Center for Evaluation of Drugs for Medical Use)
IV
Submission of the pharmaceutical product dossier to the Ministry of Health
- Compile and finalize the dossier in accordance with Federal Law No. 61
- Register on the Ministry of Health portal, filling in an electronic application
- Submit the dossier to the Ministry of Health
V
Evaluation of pharmaceutical product quality and evaluation of the expected benefit/risk ratio for use of the pharmaceutical product for medical use
VI
Completion of the registration procedure, inclusion of the pharmaceutical product in the state registry
Get advice on marketing authorization of pharmaceutical products
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Contact information
Line №1: +7 (495) 120-11-64
Line №2: +7 (495) 120-11-59
Line №3: +7 (903) 748-60-35 (English-speaking consultant)
Line №4: +7 (958) 561-33-87
WhatsApp: +7 (958) 561-33-87