Ekaterina Allen PhD, RAC U.S. FDA

Ekaterina Allen, PhD, RAC is a regulatory and quality leader with over nine years at the U.S. Food and Drug Administration, specializing in GMP compliance strategy, facility and equipment oversight, and contamination control for both CBER and CDER regulated biologics and combination products. At FDA, she has conducted numerous pre-license and pre-approval inspections, led evaluations of Form 483 remediation, and reviewed Biologics License Applications and post-marketing supplements with a focus on aseptic processes, facility design, utilities, and sterility assurance. Dr. Allen has also served as a team lead for facility reviewers and inspectors, guiding regulatory assessments of advanced manufacturing technologies and training new FDA reviewers. She has represented FDA in international regulatory collaborations and contributed to policy development through ICH initiatives. Her contributions have been recognized with multiple FDA Commissioner’s and Center-level awards, including for her work on COVID-19 vaccines and policy development for alternative inspectional approaches. She holds a PhD in Pharmacology from the University of Minnesota and an MS in Medical Science from Novosibirsk State University, and she is Regulatory Affairs Certified (US).