Susan advises life sciences and health care clients on the full range of health care regulations impacting companies operating in the industry including outsourcing facilities, manufacturers, distributors, and pharmacies. Susan counsels clients through government inspections and investigations, and assists clients in responding to Form 483s and warning letters. Susan also provides guidance to clients on how to manage recalls and regulatory meetings requests. As a member of our FDA team, Susan has experience interfacing with FDA and DEA, and advising clients on the statutes and regulations pertaining to both regulatory bodies. Susan has a particular focus on advising compounding pharmacies and outsourcing facilities in regulatory, enforcement and litigation matters. Susan successfully advocates for her clients before state and federal regulators. She frequently defends clients before state boards of pharmacy, where she has helped clients obtain positive outcomes in disciplinary and administrative proceedings.
Qualifications
Récompenses et distinctions
- Selected through peer review for inclusion in The Best Lawyers in America© "Ones to Watch" list for Transportation Law, 2024-2025