Hills’ practice focuses on the intersection of FDA and healthcare regulations, advising life sciences and health tech industry clients on a full range of regulatory compliance issues. She brings together expertise in FDA regulatory matters, healthcare regulations, and life sciences compliance.
Her work covers the full scope of U.S. regulations impacting such business activities, including federal regulatory regimes enforced by the FDA, Drug Enforcement Administration, Office of Inspector General, and, more broadly, the U.S. Department of Justice and Federal Trade Commission. She also advises on reimbursement issues, Clinical Laboratory Improvement Amendments (CLIA) oversight of diagnostic businesses, and U.S. state-level licensing, pharmacy, and distributor regulations, as well as corporate practice of medicine considerations.
In her practice, Hills manages complex issues for regulated companies, including agency engagement and product correction and recall strategies when issues arise. She provides risk assessments, develops operational procedures and compliance programs, manages medical-legal-regulatory approval processes, structures commercial licensing and collaboration arrangements, and builds strong government agency engagement strategies for product and reimbursement submissions. Additionally, she helps clients navigate challenges in product development, product launch, and ongoing market compliance while also defending against private and government enforcement actions.
