We offer full range of services in both management of the study and management of the authorization process and this saves time and helps to avoid material losses which occur due to the late introduction to the market.
Our experience and complex approach to completing the tasks guarantee total control, evaluation and support of the project! We may design a strategy for pre-clinical or clinical studies and also for introducing the drug product to the market.
We always try to facilitate development of our Partners and we try hard to please current clients and find new ones! We always offer special terms to our regular customers.
We work for those who know the price of reputation and always consider quality! Especially for you, we gathered a control group that daily examine the documentation for compliance with the regulatory standards.
Pre-clinical trial of a medical drug is performed with the help of scientific evaluation methods in order to prove safety, quality and efficacy of the medicinal drug (Art. 11 of Federal law №61-FZ dated April, 2010 « On Medicine Circulation»). Pre-clinical trial of the medical drug is performed according to the rules of Good Laboratory Practice approved by the authorized federal government agency.
Clinical study – is a study involving a human as the test subject for discovery or confirmation of clinical and/or pharmacological effects of the studied products and/or for detection of adverse drug reaction and/or for analyzing their absorption, distribution, metabolism in order to evaluate their safety and/or efficacy.
According to Part 1. art. 13 of Federal Law of the Russian Federation № 61-FZ , dated April 12, 2010 «On Medicine Circulation» drug substances are put into civil commerce on the territory of the Russian Federation if they are licensed by an appropriate authorized federal executive agency.
At the moment «SOLYUR Pharmaceuticals Group» consists of more than 40 high-quality specialists, who are professionals in their fields.
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St. Trofimova, h. 14\1, floor 2, Moscow, Russia, 115432
