Ashley provides strategic FDA regulatory and compliance advice to help pharmaceutical and biotechnology clients navigate FDA's ever-evolving regulatory framework.
Leveraging her prior experience in public health and post-market surveillance research for drugs and devices, Ashley counsels clients on a variety of questions related to FDA's complex regulatory landscape. Ashley's practice includes: product development, product lifecycle management, pharmacovigilance, human cell and tissue products, Good Clinical Practice, advertising and promotion, bioresearch monitoring, human subject protection, Freedom of Information Act, compounding, device 510K clearance, imports and exports, and due diligence.
In law school, Ashley served as a Senior Solicitations and Submissions Editor for the Howard Law Journal, where she published a note on the international pharmaceutical patent regime under the TRIPS Agreement. She also assisted low-income medical device inventors in submitting patent applications as a participant in the Intellectual Property Patent Clinic and served as an extern for the World Bank's Mediation Services unit. Before law school Ashley obtained a master's degree in public health from the Columbia University Mailman School of Public Health.
Education
Bar admissions and qualifications
