Clinical Study Design Preparation
Medical Writing
Consulting and Regulatory Support
Drug Safety and Pharmacovigilance
Project Management and Monitoring
Data Management and Biostatistics
Marketing Authorization
GMP Inspection Support
Clinical Supply Services and Logistics
Show All Services

Consulting and Regulatory Support

OCT boasts a 100% CTA approval rate across the countries where we operate: Russia, Ukraine, Belarus, Georgia, Bulgaria, Latvia, Lithuania, Moldova, Serbia.

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.

Operating in an environment with ever-evolving local and global regulatory platforms bears quite a few strategic, timeline and budget challenges. While these challenges cannot be disregarded or ignored, we do our best to make them manageable and contained. And being manageable means 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

Expertise in Eastern Europe

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 and Serbia

Experience with FDA & EMA

In addition to the thorough knowledge of 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

Request a Callback