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Antonina G. Nikolova, PhD

Vice President, CMC
Allucent

Antonina G. Nikolova is a Vice President, CMC at Allucent. She has more than 16 years of FDA and industry experience in the preparation, and review of CMC submissions in accordance with regulatory requirements of EU, USA, Canada, Japan, and Emerging Markets. In her current position as Vice President, CMC at Allucent, she has responsibility for assisting clients with Chemistry Manufacturing and Control (CMC) and related pharmaceutical development activities of drug, biologic or medical device products. She is responsible for reviewing, providing advice on, or authoring CMC-related regulatory content for Health Authority (HA) submissions, including reports, protocols, and other scientific documents. She leads and/or participates in HA communications including correspondences, teleconferences, and meetings.
Antonina serves on project teams in various capacities, e.g., as a Subject Matter Expert, Technical Lead, Assistant Consulting Project Lead, and Consulting Project Lead.
Antonina completed a Ph.D. in Human Genetics from University of Maryland at Baltimore MD.

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