Ginger Clasby, MS is a clinical and regulatory professional with extensive experience in medical product (device and pharmaceutical) development and marketing, with an emphasis on human clinical studies and program management. Most recently she served as VP, Clinical & Regulatory Affairs at Eyenovia, Inc., managing its full clinical development portfolio for ophthalmic pharmaceuticals. Prior to Eyenovia, Ms. Clasby served as VP, Clinical & Regulatory Affairs/Quality Assurance at Transcend Medical Inc. (acquired by Alcon Laboratories in 2016) where she served as the primary interface with FDA in securing approval (after IDE and pre-market review) for a novel Class III minimally invasive glaucoma surgery device. Ms. Clasby’s consulting services include regulatory strategy and project management; preparation of regulatory submissions (IDE/IND, PMA/NDA); comprehensive planning, implementation, and management of clinical studies and registries; and assistance with planning and preparing FDA Advisory Panel presentations. She holds her MS degree in Industrial Engineering and her BS degree in Math and Physics.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com