Medical Device / Pharma / Advanced Therapies
Two-step process: first National PharmCom (Regulatory Agency), then National Ethical Committee (NEC). No local ethics committees required.
Arranging the submission dossier, collecting site documents, and managing translations from English to Russian (patient documents also to Uzbek).
Submission package submitted on paper with electronic copy on USB drive to the National PharmCom for regulatory review.
After positive PharmCom conclusion, dossier is submitted to NEC for ethical review. NEC meetings are held biweekly.
Arranging the submission dossier, collecting site documents, and managing translations from English to Russian (patient documents also to Uzbek).
For medical device trials, submission goes directly to NEC (no PharmCom required). NEC meetings are held biweekly.
Agreements with study sites and investigators done in parallel to the regulatory approval process.
Obtaining import permit for investigational products.
Ancient cities of Samarkand, Bukhara, and Khiva along the legendary Silk Road
Uzbek culture is renowned for its generous and welcoming traditions
Breathtaking Islamic architecture and UNESCO World Heritage sites
Famous plov, fresh bread, and a vibrant culinary tradition
Our team will guide you through every step of the process.
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