Registration of Pharmaceuticals

Home Registration of pharmaceuticals

Рисунок13.pngDrug products are dosage forms used for prevention, diagnostics, and treatment of a disease.

For successful organization and support of drug product registration, we provide the following services:

  • Collection of documents to obtain a Russian GMP certificate for the manufacturer of pharmaceutical substances.
  • Collection of documents to obtain approval for conducting clinical trials.
  • Arrangement and monitoring of pre-clinical trials of a drug product.
  • Arrangement and monitoring of clinical trials of a drug product for its registration in the territory of the RF.
  • Registration of drug products.
  • Registration of generics as well as original drugs in Russia.
  • Registration of new developments in the case, changes in dossier.
  • Confirmation procedure of drug product registration
  • Re-registration of a drug product.


Registration workflow

Obtainment of the Russian GMP certificate for the manufacturer of pharmaceutical substances

  • Development of 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 drug product 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 the drug product according to Federal Law No. 61.
  • Determination if pre-clinical and clinical trials shall be conducted.

Pre-clinical trials

  • Selection of clinical sites for pre-clinical trials.
  • Development of clinical trial protocols
  • Arrangement and monitoring of pre-clinical trials of a drug product.
  • Statistical processing of data and final report on pre-clinical trials.

Clinical trials

  • Development and agreement of document package required to obtain approval to conduct the clinical trials.
  • Selection of clinical sites for clinical trials.
  • Getting approval to conduct the clinical trials.
  • Conduct of clinical trials, statistical processing of data, reporting, notification of the Ministry of Health on completion of clinical trials.
  • Expertise of the drug product benefit-risk by the authorised body (Federal State Budgetary Institution Scientific Centre for Expertise of Medical Products)

Submission of Product Dossier to the Ministry of Health

  • Finalization of the Registration Dossier (MF) of the drug product according to Federal Law No. 61.
  • Registration on the website of the Ministry of Health, compilation and submission of electronic dossier.
  • Submission of Product Dossier to the Ministry of Health.
  • Examination of the quality of the drug product and expertise of the benefit-risk ratio of the drug product for medical use.
  • Obtaining Marketing Authorisation for the drug product.