Drew Barlow, M.P.H.

Vice President, Head of Regulatory Affairs

Drew holds a BS Degree in Biology from Mount St. Mary’s College and a Master’s in Public Health from University of North Carolina at Greensboro. Drew has over 14 years of regulatory experience, including 4 years with the US FDA as a GMP investigator. He maintains extensive knowledge of global pharmaceutical CMC regulations and guidance documents pertaining to products in clinical development through post-marketing applications commercialization with emphasis in the EU, USA, Canada, Japan, China and Australia. His areas of expertise include: devising and implementing CMC strategies, IND/IMPD/NDA/MAA preparation, post-approval compliance and regulatory reporting, GMP inspection readiness, and Quality by Design implementation.