Areas of our special expertise
Preparation of documentation packages to be submitted when in the process of obtaining a clinical trial approval from the Regulatory Authorities and Local Ethics Committees, including:
- Obtaining import and export licenses;
- Current filings to regulatory authorities and LEK;
- Regulatory activities at the project completion stage;
Local Regulatory Expertise
The long-term experience of our specialists allows us to obtain approval for conducting clinical trials in countries where OCT is present (Russia, Kazakhstan, Belarus, Armenia, Kyrgyzstan) in the shortest possible time.
Since 2010, when the Russian Federal Law ‘On the Circulation of Medicines’ was adopted, our company has not received a single refusal to conduct a clinical trial from the Ministry of Health of the Russian Federation.
Submissions to the FDA and EMA
In addition to our deep expertise in the field of local legislation, OCT also has successful experience in supporting Sponsors in global regulatory matters:
- Successful pre-registration meetings with FDA local and international pharmaceutical companies;
- EMA advisory meetings without significant findings;
- Preparing applications for registration of experimental medicines with the FDA;
- Obtaining orphan status of candidate drugs with the EMA and the FDA.
