Technology Implementation Center
Guryev
Artem M.
Телефон: 8 (3822) 901-101 (extens. 1859)
Адрес: 2g Moskowski Trakt Street, building 18, room 10
Analytical laboratory: 8 (3822) 901-101 (extens. 1864)
Pilot-scale production unit: 8 (3822) 901-101 (extens. 1865)
Clean room facilities – material preparation: 8 (3822) 901-101 (extens. 1868)
Clean room facilities – manufacturing of active pharmaceutical substances: 8 (3822) 901-101 (extens. 1871)
Clean room facilities: 8 (3822) 901-101 (extens. 1869)
Электронная почта: center.vner.teh@ssmu.ru
Technology Implementation Center deals with development and implementation of technologies for production of active pharmaceutical substances and dosage forms, medical devices and diagnostic kits, as well as dietary supplement and cosmetic products. Pilot-scale production of SSMU Technology Implementation Center, designed in accordance with GMP EU, totally meets the requirements of the Russian and European standards for premises and equipment of the pharmaceutical industries.
Our area of competence includes development of production technologies, elaboration of standardization methods, technological regulations and instructions, monographs, specifications, and other regulatory documents as well as organization of pre- and post-clinical studies (including bioequivalence), compiling of registration dossiers and support of the process of state registration and certification of new products for human and veterinary medicine.
Directions of activity:
Development of technologies and manufacturing of pilot runs:
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Of innovative drugs
- inventive substances (active pharmaceutical substances)
- me-too drugs
- well-known drugs with new prescription
- new (including innovative) drugs with known APS
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Of generic drugs
- with expiring patent
- orphan drugs
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Of parapharmaceutical production
- diagnostic kits
- dressing materials
- biologically active additives
- cosmetics
Characteristic features of Technology Implementation Center:
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Advantages of cooperation with Technology Implementation Center:
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Who we are working for
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