Consulting and Regulatory Support
OCT boasts a 100% CTA approval rate across the countries where we operate: Latvia, Poland, Serbia, Georgia, Bulgaria, Ukraine, Lithuania, Moldova, Russia, the Netherlands, Spain.
OCT boasts a 100% CTA approval rate across the countries where we operate: Latvia, Poland, Serbia, Georgia, Bulgaria, Ukraine, Lithuania, Moldova, Russia, the Netherlands, Spain.
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
• 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
Strong local expertise provided by our in-house regulatory and marketing authorization specialists, allows OCT Clinical to address a wide range of potential regulatory hurdles.
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
