Regulatory support

Our regulatory affairs professionals have a deep knowledge of national legislation on clinical trials and expertise in working with regulatory agencies and ethic committees both in Russia and in Ukraine. We are committed to careful preparation of all documents for RA and EC submission and make sure that regulatory approval process runs without delays.

We provide the following services:

• Development/review of informed consent forms
• Preparation of submission dossier
• Negotiation with insurance companies on compulsory trial subjects' insurance
• Overall regulatory support throughout the study
• Obtaining of import/export licenses
• Submissions to local ethics committees

If you are interested in regulatory related services provided by our company, just This e-mail address is being protected from spambots. You need JavaScript enabled to view it or call Dr. Andrey Tarakanov.