Navigate the complexities of FDA regulations with confidence
GCP compliance to properly validate clinical performance
Expert guidance in manufacturing of all FDA-regulated products in conformance with cGMP.
Deetailed guidance on technical requirements for all pre-market applications covering drugs, devices and biologics.
Helping clients prepare for and respond to FDA inspections, Warning Letters, and other enforcement actions.
Ensuring compliance with FDA regulations on drug labeling, marketing, and promotional materials.
Amy holds a B.S. in Biology and an A.A. in Chemistry from Thomas More University. Currently, she is a second-year law student at the University of Kentucky J. David Rosenberg College of Law, with a J.D. expected in 2026. Last summer, she interned with St. Jude Children's Research Hospital, gaining experience in legal aspects of research and healthcare.
