Deepa Deshpande Ph.D Email & Phone Number

Regulatory Affairs professional with over 20 years of experience in pharmaceutical industry, with multi-functional expertise in Regulatory Affairs (clinical, nonclinical and CMC). Strong technical background in pharmaceutical development with knowledge of domestic and international regulatory environments, successful interactions with various Health Agencies and other Government Agencies (e.g pre-IND, EOP2, pre-NDA, Type C, EU Scientific Advice). Accomplishments include IND/CTA/DMF filings, NDA/MAA preparation, review and planning, successful interactions with US and ex-US health authorities, orphan drug designations. Experience working with Government research funding organizations such as BARDA, DARPA, NIH.Recognized contributor in pharmaceutical community, twice elected by membership of pharmaceutical organization (AAPS) to a leadership role, served as chairperson and speaker at several workshops, symposia on topics related to regulatory affairs and product development.Winner of Woman Entrepreneur of the Year award 2022-2023, Indian Achiever's Form. Honored listee Marquis WhosWho.Specialties: IND, CTA, DMF, NDA/BLA/MAA preparation, 505(b)(2) applications, Interactions with Health Authorities, Regulatory Strategy/Product Development Plans, SBA Review and Analysis, Regulatory oversight clinical trials, Due Diligence, Orphan Drug Designation, Special Protocol Assessments, Fast Track Designation, Breakthrough designation request Technology Platforms: Small molecules, Biologics, Biosimilars, Immuno-oncology, Controlled Release & Inhaled Therapeutics, Fixed dose & Drug-Device Combinations, Oligonucleotide/Cell and Gene Therapy, Controlled Substances

Listed skills include Regulatory Affairs, Pharmaceutical Industry, Drug Development, Ind, and 46 others.