06.Apr.2012

OCT Clinical Trial in Central and Eastern Europe consults big pharma on Regulatory in Russia

In accordance with the agreement OCT is going to provide regulatory affairs advice at all stages of product development, from the early concept stage, through product development, up to and beyond submission of a dossier for marketing authorization in Russia

We are happy to announce that OCT signed an agreement with a top ten pharma to provide consultancy services.

In accordance with the agreement OCT is going to provide regulatory affairs advice at all stages of product development, from the early concept stage, through product development, up to and beyond submission of a dossier for marketing authorization in Russia.

It is well known that current legislation in Russia caused a lot of concerns and questions from Russian and international companies. On April 12, 2010 the President of the Russian Federation signed the new Federal Law “On the Circulation of Medicines” (the “New Law”) thus completing the procedure of its adoption. The New Law was to replace the existing Federal Law No. 86-FZ “On Medicines” dated June 22, 1998, as amended (the “Law on Medicines”). The law introduced several dramatic changes. The law aimed at improving regulatory environment in the Russian Federation but it turned out to be a big issue for pharmaceutical industry. The law still causes a lot of questions and controversies.

OCT will provide regulatory input into the client’s product development strategy.

It is well known that the key to any successful regulatory strategy is a fruitful interaction with the relevant regulatory agency. OCT-Clinical trials in Central and Eastern Europe is a local expert that has good connections and relations with regulators and experts in Regulatory Authorities in Russia. OCT is happy to assist the client interpret current Russian legislation and find solutions for a more rapid drug development and registration. We will provide our client with different regulatory scenarios to speed up market authorization.

OCT are very glad to assist our client seek advice and opinions of regulators and experts in Russia