Dr. Deepa Deshpande, PhD, RAC
President, Universal Regulatory, Inc.
Regulatory Affairs development professional with over twenty years of experience in pharmaceutical industry, with multi-functional expertise in Regulatory Affairs (clinical, nonclinical and CMC). Primary focus is to help clients develop and execute regulatory strategy through product approval. Strengths include a strong technical background in pharmaceutical development for small molecule, biologics, and combination products development. Experienced in negotiating with US and international regulatory authorities. Accomplishments include IND/CTA/NDA/DMF filings and maintenance, NDA/MAA preparation, review and planning, orphan drug designation, successful interactions with US and EU Health Agencies.