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Expert Profile


Olga Pavlova
Regulatory Manager, Amarex Clinical Research LLC

Olga Pavlova, PhD, Regulatory Manager; Dr Pavlova is one of Amarex’s leading regulatory experts. She has written all sections of applications for IND, NDA, ANDA, BLA, IDE, PMA and ODD. Her experience includes writing IND submissions and regulatory documents; Investigator Brochures, annual reports, and clinical protocols. Dr Pavlova conducts gap analyses of product development programs which are then used to create FDA regulatory approval strategies in a wide range of therapeutic indications for small molecule drugs, biologics and devices. Before joining Amarex Dr. Pavlova gained experience in developing portfolio strategy, due diligence and invention marketing while doing an internship at The Center for Advancing Innovation, Inc. Dr Pavlova has over nine years of research experience in the area of molecular biology, microbiology and biochemistry.

Dr. Pavlova completed her graduate work at the Institute of Gene Biology, Russian Academy of Sciences and the Waksman Institute of Microbiology, Rutgers University, NJ and earned her PhD degree in Biology. She completed her postdoctoral work on food borne pathogenic bacteria virulence factor secretion at the National Institutes of Health, Bethesda, MD. She also earned her Masters degree in Biochemistry from the Moscow State University, Moscow, Russia.

Trainings by Expert

Electronic Submissions to the FDA - eCTD Requirements
Category: Drugs and Chemicals (Pharma)