Since 2005, we have been guiding our sponsors through the intricacies of the regulatory system both when dealing with the Ministry of Health of Russia and FDA or EMA. In addition to clinical trial approval, our goal is to help our clients develop and implement the most optimal registration strategy in order to speed up market access.

Alt

Operating in an environment with the ever evolving local and global regulatory platform bears quite a few strategic, timeline and budget challenges. While these challenges cannot be canceled or ignored, we do our best to make them manageable and contained. And being manageable stands for pursuing our clients’ best interests.

Natalya Eliseeva Regulatory Manager

Specialized areas of expertise 

 Document review as a part of preparation for a clinical trial application
 Development of the regulatory strategy
• CTA submission to the local regulatory authorities
 Obtaining of import/export permits for drug import and export of biological samples
 QP release for EU countries


Local regulations
Strong local expertise provided by our in-house regulatory and marketing authorization specialists, allows OCT to address a wide range of potential regulatory hurdles. 
Since 2010, when the new Federal Law “On the Circulation of Medicines” came into force, OCT has not received a single refusal from the Ministry of Health of the Russian Federation when submitting clinical trial applications.
Likewise, OCT has the same level of success in obtaining clinical studies approvals across the countries of our operation: Ukraine, Belarus, Georgia, Bulgaria, Latvia, Lithuania, Moldova, Serbia


Experience with FDA & EMA
In addition to the thorough knowledge of the local regulatory specifics, we are proud of a solid track record in assisting our sponsors with global regulatory activities as follows:
• Successful experience in conducting pre-IND meetings with FDA.
• Scientific advice meetings with EMA
• Submitting NDA applications to FDA
• Obtaining orphan drug status from EMA & FDA