The legislative framework for conducting clinical research has now been fully established in the Russian Federation. These activities are regulated by the Ministry of Health Care and Social Development and, in particular, by the Federal Service for Supervision in the Sphere of Health Care and Social Development. Prior to obtaining approval for clinical trial of an investigational product on the territory of the Russian Federation, the study documents (protocol, Investigator's Brochure, informed consent, etc.) have to pass expert examination in the Ethics Committee under the Federal Body Controlling Quality of Medicinal Products, Independent Inter-Disciplinary Committee for Ethical Expertise of Clinical Trials. Congenix provides the following services:
- obtaining approval for clinical trial from the Federal Service for Supervision in the Sphere of Health Care and Social Development;
- preparation and submission of documents for the ethical expert examination and obtaining approval for clinical trial from the ethics committees;
- preparation of a document package for submission to regulatory authorities of the European Union states, U.S.;
- obtaining licenses for the entry of investigational product and study supplies into the customs territory;
- obtaining license for the exist of biological samples out of the customs territory;
- customs clearance of the investigational product and study supplies.
Congenix maintains close relations with the local regulatory and permitting authorities. This enables us to considerably cut down the time required for acquisition of the necessary permissions and approvals, which saves resources for our clients.