Dr. Elora Gupta

Partner, Drug and Device Advisory Group

Industry/Field

FDA, SBIR

Bio

Regulatory strategy for a medical drug/device provides the foundation for a streamlined development program and expedited FDA review leading to a marketed product with an optimal profile that addresses an unmet need. Elora has about 20 years of experience serving as Global Regulatory Strategy Lead and FDA Liaison for drugs and devices including digital medicine. She is currently working with several CMU startups to identify optimized, science-based regulatory pathways leveraging new FDA initiatives, develop product roadmap and engage with FDA for a least burdensome and successful product registration. Elora also guides the prospective integration of regulatory and reimbursement strategies for payor coverage to enhance product access. Elora has recently served as a reviewer for National Science Foundation SBIR/STTR grants.