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Elora Gupta

Greater New York City Area

Elora Gupta, PhD, is with Carnegie Mellon University, Center for Innovation and Entrepreneurship, serving as regulatory advisor for drug and device startups. She has held senior leadership positions in Global Regulatory Affairs at Bristol-Myers Squibb Pharmaceutical Company and Otsuka Pharmaceuticals and academic positions at Rutgers College of Pharmacy and Cancer Institute of NJ. She holds a PhD from Ohio State University College of Pharmacy and has completed postdoctoral fellowship at University of Chicago. Pritzker School of Medicine.

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Areas of Expertise

  • FDA Liaison for Drugs and Devices

    Lead Regulatory Strategy and FDA Engagement for a streamlined development and approval of drug/device product with a competitive profile

    • Regulatory
    • FDA clearance and approval
  • Global Regulatory Lead

    Streamline development and global Health Authority engagement for 'simultaneous' global drug registration

    • Regulatory
    • International regulatory
  • Competitive Target Profile for Drugs and Devices

    Prospective development of an optimal target profile leading to product labeling based on comparative analysis, FDA precedents and opportunities to differentiate drug and device from competition

    • Regulatory
    • FDA clearance and approval
    • Labeling

My Interests

Health Sectors
Medical Devices, Digital Health, Pharmaceuticals, Diagnostics

Experience

  • Partner

    Drug and Device Advisory Group | December 2016 - Current

    Regulatory Strategy for Startup Drug and Device Companies Blog : http://druganddevicedigest.com/ Associated with Carnegie Mellon University Startups Andrew Carnegie Society Member Carnegie Mellon University Loyal Scot