Real Humans

Elora Gupta, PhD

Regulatory Strategy

Elora has over two decades of experience in FDA regulatory strategy for streamlined medical product development and expedited FDA review for marketing authorization with optimal labeling claims. Elora worked at Bristol-Myers Squibb and at Otsuka serving as Global Regulatory Strategy Lead and FDA Liaison for drugs, devices, diagnostics and combination products including digital medicine. She is currently President of Drug and Device Advisory Group and is an Advisor at the Swartz Center for Entrepreneurship, Carnegie Mellon University (CMU). In this role, she works with CMU startups to identify least-burdensome, science-based regulatory pathways leveraging current FDA guidances, new FDA programs and initiatives and engaging with the Agency for successful product development and review. Elora also guides the prospective integration of regulatory and reimbursement strategies for payor coverage to enhance product access. Recently, Elora’s interest has been in enhancing product regulatory strategy to include health and safety directives of federal agencies like OSHA, CDC, EPA that highlight person-centric needs for well-being and quality of life. 

Elora has been a reviewer for National Science Foundation SBIR/STTR grants and Military Medicine and is a community educator for Alzheimer’s Association

Elora has a PhD in Pharmaceutical Science from the Ohio State University, College of Pharmacy, and completed a postdoctoral fellowship at the University of Chicago, Pritzker School of Medicine. She also has certifications in occupational advanced safety and occupational hearing conservation.

“Begin with the End in mind for a successful regulatory strategy.”

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