Holli S. Vaughan, MS, RAC

Holli S. Vaughan, MS, RAC

Group Leader, Project Management

Ms. Vaughan joined Biologics Consulting in March 2000 with 12 years of prior regulatory affairs experience. She has provided clients with regulatory guidance, project management and submission support with respect to INDs, marketing applications and all related amendments and supplements (paper and electronic, legacy and CTD format). Ms. Vaughan also assists with U.S. Agent requirements, Orphan Drug Designations, establishment registrations and product listings, and document QC.


MS, Biology, Johns Hopkins University; Interdisciplinary Scientific Studies, Baltimore, MD (1995)

BS, Biology, Mary Washington College, Fredericksburg, VA (1988)


2001-present Regulatory Affairs Certification (RAC)