EDWARD NARKE

Edward Narke
Principal

Head of CMC Regulatory Affairs and submissions practice. Ed began his career in the manufacture of active pharmaceutical ingredients (API) and lead the International Compliance Program at Wyeth Pharmaceuticals before moving into Regulatory Affairs. Ed has authored 100+ regulatory submissions and the clinical trial applications for multiple compounds in various therapeutic areas such as oncology, cardiovascular, anti-inflammatory and pain (Phase 1 – Phase 3). His experience spans small molecule and biologic in a wide range of oral, parenteral, topical and inhalation drug dosage delivery forms. Ed’s has held positions at YM BioSciences Inc, Wyeth Pharmaceuticals, and Lonzagroup Inc. Ed completed Masters of Science in Organic Chemistry from Villanova University and B.Sc. Chemisty at the University of Pittsburgh.

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