Clinical trials in Russia
Trials, product development and registration managed by DOKUMEDS
With 140 million of population Russia represents an important market sector for Pharmaceutical companies.
The Federal Law of Russian Federation „On circulation of medicines” requires that staring from 01-Sep-2010 for registration of the medicinal product in Russia Clinical trials must be conducted in the territory of the Russian Federation. The same time, more strict and specific requirements are formulated for conducting of Clinical trials in Russia.
Today, experienced local based CRO can become a critical success factor for foreign Pharma companies looking for clinical development of their products and following authorization in Russia Federation.
DOKUMEDS is a CRO operating in Russia almost 10 years, and during these years, has become an expert in management of Clinical trials and Regulatory procedures in Russia able to evaluate the evolving regulatory landscape, to plan effective risk-management, and to provide dynamic solutions in rapidly changing local environment.
In the first quarter of 2011, DOKUMEDS has managed to keep the same level of successful submissions of Clinical trials in Russia as 2010, before the changes in local legislation were implemented.
Since 2005 DOKUMEDS representative office is opened in Moscow, the capital of Russia. In 2009, understanding the increasing need of safe, time and cost effective local logistics chain for Clinical trials supplies, DOKUMEDS has opened its own warehouse in Moscow.
