Regulatory Support for Clinical Studies

Regulatory Support for Clinical Studies from Accell Clinical Research LLC

By: Accell Clinical Research LLC  07/30/2016
Keywords: Regulatory Support for Clinical Studies

Russia, Ukraine, Baltic States and neighboring countries continue to be increasingly attractive areas for conductig clinical trials in pharmaceuticals and medical devices. The regulatory requirements in these countries can be challenging to navigate, however. We provide consultation and support for obtaining regulatory approval and ethics approval for conducting clinical trials in each country, and maintain communication with regulatory authorities during the clinical study. - Regulatory strategy consultation; - Procurement of approval to conduct clinical trials from Regulatory Authorities and Ethics Committees; - Procurement and management of import and export licenses where applicable; - Communication with Regulatory Authorities throughout the study.

Keywords: Regulatory Support for Clinical Studies

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