Registration of pharmaceutical products (PP). Registration of pharmaceutical substances.

Our services for organizing and supporting registration of pharmaceutical products include:

  • 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;
  • 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.

Preliminary evaluation of dossier

  • Perform an initial evaluation of the dossier and provide client consultation
  • Determine whether there is a need for preclinical (PCS) and clinical (CS) studies in accordance with Federal Law No. 61-FZ dated April 12, 2010, On the Circulation of Pharmaceutical Products as amended on December 29, 2015
  • Evaluate the completeness of the materials submitted and their compliance with the registering agency requirements
  • Calculate the cost of registration and come to an agreement with the client

Preclinical studies of the pharmaceutical product if applicable, as determined in Stage I

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)

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

Evaluation of pharmaceutical product quality and evaluation of the expected benefit/risk ratio for use of the pharmaceutical product for medical use

Completion of the registration procedure, inclusion of the pharmaceutical product in the state registry

The list of documents and data required for registration of finished pharmaceutical products

GMP inspection of foreign manufacturers

To receive a detailed consultation on pharmaceutical product (PP) registration in Russia, use the form below.

Contact us

If you have any questions or would like to contact us for some reason, please, use this form on the right. We do our best to respond as quickly as possible. Please, enter your real telephone number and we will call you back soon. Also, if you would like us to call you back with a certain answer to your question, then please, describe it in detail in this message. We are looking forward to hearing from you!

Contact information

Telephone №1: +7 (495) 120-11-64
Telephone №2: +7 (495) 120-11-59
Telephone №3: +7 (903) 748-60-35 (English — speaking consultant)