- Specialist in Regulatory Affairs
- Regulatory Compliance
- Federal Healthcare Policy
Madeleine Giaquinto is a Manager of Regulatory Affairs at Greenleaf Health, Inc. Madeleine provides clients with timely analysis of FDA regulations, policies, and guidances related to good practice standards for drugs, biologics, and medical devices. In addition, she advises clients on strategic engagements with FDA concerning a range of compliance issues, including remediating deficiencies identified in FDA Form 483 observations and FDA warning letters and building cultures of quality within mature quality management systems.
Before joining Greenleaf Health, Madeleine worked as part of the legal and government relation teams at 340B Health, a membership organization of public and private nonprofit hospitals and health systems in the federal 340B drug pricing program. Her role involved researching and analyzing implications of 340B development and educating members on issues involving program compliance, implementation, and advocacy strategies.
Prior to 340B Health, Madeleine worked at Mintz Levin Strategies where she analyzed the development of federal healthcare policies and developed tools of analysis for proposed health legislation in Congress. Additionally, Madeleine worked at MedStar Georgetown University Hospital managing provider credentialing requirements of various regulatory authorities. Her time at MedStar prompted her to advance her health policy ambitions and pursue a legal education, focusing her studies in health law and policy and FDA regulatory coursework.
Madeleine received a B.S. in Biology from Georgetown University and a J.D. degree from George Mason University School of Law.