Alisha S. Miller

Alisha S. Miller is a senior regulatory affairs and quality systems leader with more than 20 years of experience across FDA, medical devices, in vitro and companion diagnostics, biologics, and pharmaceuticals. A former FDA reviewer with CBER, she has managed the full lifecycle of IND, IDE, NDA, ANDA, BLA, PMA, and 510(k) submissions and authored international registration dossiers across global markets. As Owner and Principal Consultant of Essential Quality & Regulatory Solutions and previously Global Regulatory Program Manager at Agilent Technologies, where she secured 150+ IVD registrations, she advises on U.S. and global regulatory strategy, submission readiness, and quality systems compliance. She holds an M.S. in Bioscience Regulatory Affairs from Johns Hopkins University and is an ISO 9001 Lead Auditor and ISO 13485 Internal Auditor.