Our Team

Alisha Miller is the Regulatory Affairs Business Unit Lead at Biologics Consulting Group, Inc. She brings more than 20 years of regulatory strategy, project management, quality, and compliance experience across biologics, vaccines, pharmaceuticals, medical devices, in vitro diagnostics (IVDs), and companion diagnostics. A former FDA Consumer Safety Officer and Regulatory Project Manager, she combines agency and industry perspectives to guide product development and submissions.

Ms. Miller leads the business unit’s strategic direction and operations and advises clients on global regulatory pathways, submission strategies, risk-based decisions, and program execution. Her responsibilities include business development, client engagement, resource allocation, team development, and cross-functional project oversight.

At FDA’s CBER, she managed lifecycle review activities for INDs, IDEs, NDAs, ANDAs, BLAs, and 510(k)s and supported IVD and device reviews and implementation of the Pre-Submission process under MDUFA III. In CDER’s Office of Compliance, she prepared analyses and recommendations supporting regulatory decisions, compliance actions, enforcement, and post-market oversight.

In industry and consulting, she has led global strategies and submissions for companion diagnostics and IVDs, including PMAs and supplements, and supported more than 150 product registrations across Europe, Latin America, Asia-Pacific, and the Middle East. She has prepared clients for FDA meetings, served as U.S. Agent, and supported a COVID-19 vaccine IND with CMC and GMP considerations. Earlier roles included quality systems, audits, CAPA, training, ISO 13485 implementation, and design controls.

Ms. Miller holds an M.S. in Bioscience Regulatory Affairs from Johns Hopkins University, a B.S. in Biology from the University of Arkansas at Pine Bluff, and a Master’s Certificate in Project Management from The George Washington University. Her certifications include ISO 9001 Lead Auditor and ISO 13485 Internal Auditor; her affiliations include the American Society for Quality and the Regulatory Affairs Professionals Society.