Universal Regulatory

Universal Regulatory is a regulatory affairs consultancy founded in 2009 and headquartered in the San Francisco Bay Area. The company provides comprehensive strategic and tactical regulatory consulting services to pharmaceutical, biotechnology, and medical device companies globally. Its team has deep technical expertise spanning small molecules, biologics, combination products, and biosimilars. They support clients from early development stages (pre-IND/CTA) through clinical trials to marketing applications (NDA/BLA/MAA) and post-marketing lifecycle management.

The firm is led by Dr. Deepa Deshpande, PhD, RAC—an industry veteran with over 22 years of experience—and has supported more than 60 pharma/biotech companies as an advisor or interim head of regulatory affairs. Their projects include successful INDs for oncology products, NDA filings for drug-device combinations, biosimilar strategy/due diligence work, global Phase 3 program support at top pharma firms, orphan drug designations advice, fast track/breakthrough designation requests preparation.