Natalia Pripuzova
Chief Executive Officer, Founder,
Global Regulatory Affairs, CMC
Global Regulatory Affairs, CMC
Dr. Pripuzova founded NPDK Bioconsulting in 2021 and is serving as company's Global Regulatory CMC Principle Consultant. She has Master's Degree in Biology from Moscow State University named by Lomonosov and PhD in Virology from Chumakov Institute of Poliomyelitis and Viral Encephalitis, Moscow. Upon defending PhD in 2005 Natalia has spent most of her scientific and regulatory career in United States.
Dr. Pripuzova served as Product Quality Reviewer at the Office of Pharmaceutical Quality, US FDA, CDER, where she completed multiple original BLA, IND phase II-III and pre-BLA packages, and post-approval supplements reviews of Module 3 (CMC) and participated in several Pre-License Inspections (PLI) of Drug Product and Drug Substance manufacturing facilities across USA.
Before joining CDER, US FDA Natalia worked at the Office of Cellular, Tissue and Gene Therapies, CBER, US FDA, where she led several research projects related to regulatory science of cellular and gene therapies. Before joining US FDA Natalia completed a post-doc at National Cancer Institute (NCI), National Institutes of Health (NIH), USA and has contributed to over 15 scientific publications and book chapters as a lead author in various biology fields.
In 2017 Dr. Pripuzova transitioned to biotech industry and became a Head of International Regulatory Affairs Group at R-Pharm, JSC. Natalia led the worldwide CMC Regulatory strategy and submissions across the company's biologics portfolio from Phase I-III to pre-BLA stage. In 2020, Natalia has become an Independent Consultant continuing regulatory support to R-Pharm, JSC, BioNTech (Germany), NanoClimate (USA), ADC Therapeutics and other biotech industry leaders.
Dr. Pripuzova served as Product Quality Reviewer at the Office of Pharmaceutical Quality, US FDA, CDER, where she completed multiple original BLA, IND phase II-III and pre-BLA packages, and post-approval supplements reviews of Module 3 (CMC) and participated in several Pre-License Inspections (PLI) of Drug Product and Drug Substance manufacturing facilities across USA.
Before joining CDER, US FDA Natalia worked at the Office of Cellular, Tissue and Gene Therapies, CBER, US FDA, where she led several research projects related to regulatory science of cellular and gene therapies. Before joining US FDA Natalia completed a post-doc at National Cancer Institute (NCI), National Institutes of Health (NIH), USA and has contributed to over 15 scientific publications and book chapters as a lead author in various biology fields.
In 2017 Dr. Pripuzova transitioned to biotech industry and became a Head of International Regulatory Affairs Group at R-Pharm, JSC. Natalia led the worldwide CMC Regulatory strategy and submissions across the company's biologics portfolio from Phase I-III to pre-BLA stage. In 2020, Natalia has become an Independent Consultant continuing regulatory support to R-Pharm, JSC, BioNTech (Germany), NanoClimate (USA), ADC Therapeutics and other biotech industry leaders.
