Recently GCT was awarded a new regulatory project by a Greek Pharmaceutical company. It aims to develop a novel fixed-dose combination of the currently approved active substances doses into an immediate release film-coated tablet. The intended indication is “common cold with fever and nasal congestion”.
It was important to the Sponsor to receive advice from the Russian regulatory authority – Ministry of Health – on the best approach to clinical development. GCT expertise was requested to obtain the regulatory feedback on the clinical studies strategy, and marketing authorization path of the medicinal products in the Russian Federation.
Contact bd@gctrials.com, if you need help with clinical trials and marketing authorization for drugs and medical devices in Russia.