Laura Macherelli advises healthcare, life sciences, and pharmaceutical firms on navigating regulatory frameworks to ensure compliance with licensing, reporting, and operational requirements across diverse business models, including online, mail order, compounding, and traditional healthcare providers. Applying her experience working with the U.S. Food and Drug Administration (FDA), she helps clients navigate the complex and frequently changing compliance regulations at the international, national and state levels. Laura’s practice includes:

• FDA Compliance – Counsels clients on FDA and other regulatory agency inspections, responses to Form 483 observations, product recalls, and adherence to Current Good Manufacturing Practices, mitigating enforcement risks and ensuring business continuity.
• Pharmaceuticals – Provides regulatory guidance on product development, advertising, and labeling to pharmaceutical companies.
• Strategic Transactions – Advises clients on compliance and transactional matters, including mergers, acquisitions, investments, change of ownership, and expansions into new markets.

Prior to joining Bass, Berry & Sims Laura was an associate at BakerHostetler in Washington, D.C. She previously served as regulatory counsel at the FDA, Center for Tobacco Products and as a corporate compliance fellow at Otsuka Pharmaceuticals. During law school, Laura was a House of Representatives legal intern for the Committee on Oversight & Government Reform and a marketplace appeals legal intern with the Centers for Medicare & Medicaid, Office of Hearings and Inquiries. She earned a law degree, with a Health Law Certificate, from the University of Maryland Francis King Carey Law School; a Master of Public Health from George Washington University, Milken Institute School of Public Health; and a Bachelor of Science in health sciences from the University of Maryland, College Park.