R&D Center
The Center for the Development and Registration of Medicines operates in such areas as direct thrombin inhibitors, anticoagulants, antitumor, antitussive, immunosuppressive, hepatoprotective, and antiviral (including HIV) agents, as well as antibiotics.
19
employees
9
nosologies
27
drugs in the pipe-line
Our goal is to increase the production of socially significant domestic drugs and ensure the availability of high-quality and safe medicines for the population.
Our goal is to increase the production of socially significant domestic drugs and ensure the availability of high-quality and safe medicines for the population.
Main directions
Development of the composition and technology of production of dosage forms
Stability studies of the developed dosage forms
Research on the effectiveness and safety of drugs (preclinical and clinical studies) based on large scientific centers of the Russian Federation
Development and validation of control methods for finished dosage forms
Standardization of drug quality requirements in accordance with international and regulatory requirements of the Russian Federation
A full cycle of registration of medicines in accordance with the requirements of the EAEU and the transfer of technology and control methods to the production site.
The research approach
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High standardRequirements Orientation " of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical Products Intended for Human Use (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), and Q8.
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Current level of requirementsConstant monitoring of the current level of requirements for the quality of medicines from leading international organizations, foreign and domestic pharmacopoeias, and regulatory authorities of the Ministry of Health of the Russian Federation to ensure the competitiveness of the drug at the pharmaceutical development stage.
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Modern methods of controlApplication in the development of chromatographic control methods, validation of analytical techniques, application of modern trends and approaches to the development of new products and to the reproduction of formulations of reference drugs.