Principal Consultant

Elizabeth Fenna

Liz excels at advising companies on their development and life-cycle management strategies to meet expectations of regulatory agencies around the world. She applies her skills to a broad range of therapeutic areas and has successfully helped numerous clients interact with regulatory agencies throughout various stages of development and during regulatory review.

Key areas of expertise
  • Extensive expertise working with the US FDA
    • Over 30 years of experience working in large global PhRMA companies, small start-up companies, and consulting firms
  • Broad knowledge of US requirements for development of small and large molecules including plasma-derived therapies
  • Experience with development programs for treatment of rare diseases and orphan drug designations
  • Led multiple meetings with the FDA, including Pre-IND, End-of-Phase 2 and Pre-NDA Meetings
  • Led and contributed to multiple successful FDA applications, including INDs, NDAs, and BLAs in therapeutic areas including inflammatory conditions, respiratory, pain, ophthalmology, rare diseases and innovative therapies
  • Extensive knowledge of post marketing requirements including periodic reporting, pharmacovigilance, and annual reporting
Before NDA

Liz was Global Regulatory Lead for a large, global PhRMA company responsible for the top revenue generator. She began her career as an analytical chemist after graduating from St. John’s University, NY, NY and then spent time in Quality Assurance for a large generic drug manufacturer before moving into Regulatory Affairs.  Starting by supporting generic products, moved into extended-release dosage forms and then into development and commercialization of prescription drug products for a large PhRMA company.

Liz also worked with many start-up companies as an employee and a regulatory consultant.

 

Elizabeth Fenna

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