Debra M. Leibold, MD, PhD

Debra M. Leibold, MD, PhD is a pharmaceutical regulation expert specializing in labeling strategy and compliance within the global pharmaceutical industry. With a career spanning clinical risk management, safety surveillance, and regulatory labeling, she brings a strategic framework to litigation work involving complex pharmaceutical labeling disputes. Her work centers on investigating labeling inconsistencies, assessing regulatory compliance, and evaluating whether safety standards have been met.

Dr. Leibold has been retained in numerous expert witness and consulting engagements across the US, EU, and Japan, involving cases related to pharmaceutical labeling, regulatory compliance, and safety surveillance. Her MD and PhD in Medicine and Molecular Biology, along with her Medical Physician & Surgeon license in Pennsylvania, reinforce her ability to deliver objective, defensible analyses. She is regularly engaged by both plaintiff and defense counsel to provide clear, independent determinations of regulatory compliance in disputes involving pharmaceutical labeling and safety standards.