Biography

Vineeta Sharma is a regulatory and Compliance Consultant whose strength lies in pre-clinical/clinical methods and strategies, Pre-IND, IND, BLA, 510 (k), PMAs, regulatory writing (clinical study reports, protocols, investigator brochures, FDA briefing packages, informed consent forms). She has a Ph.D. in Hematology from the all India Institute of Medical Science. During her time at UC Berkeley, she completed the Professional Program in Regulatory Affairs, the Professional Program in Quality and Compliance for Biotechnology, and the Clinical Research Conduct and Management Program.

Industry Experience

Biomarker Discovery, Product Development Scientist-Gene Therapy, Post Doctoral Fellow for Gene Therapy

Expertise

Gene therapy, Cell therapy, Rare disease, Hematology, Obesity, Diabetes, Oncology, Medical devices

Universities Mentored For

Vineeta Sharma

San Francisco Bay Area

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