Established in 2002, our Research Triangle Park office was formed to respond to
the unique profile and legal needs of businesses located in the largest research
park in the United States. Home to more than 200 companies, Research Triangle
Park’s success reflects its strategic proximity in North Carolina to three
world-class research universities: North Carolina State University, Duke
University, and University of North Carolina at Chapel Hill.
Our Research Triangle Park office serves as the hub for one of the largest
healthcare legal teams in the United States. Serving a national and
international client base, our team provides legal and professional consulting
services to a wide range of healthcare clients, including academic medical
centers and research institutions, hospitals and health systems, pharmaceutical
companies, clinical laboratories, long-term care facilities, accountable care
organizations, clinically integrated networks, and numerous specialty providers.
Our Healthcare and FDA team assists clients on the full array of legal issues
facing healthcare providers in an ever-changing and highly complex, regulated
industry—including federal regulatory compliance matters, Medicare
reimbursement and enrollment, government and internal investigations, and
complex supply chain arrangements. In the area of life sciences, our lawyers
serve a diverse client base, encompassing clinical research organizations,
biotechnology, pharmaceuticals, diagnostics, healthcare, bio-manufacturing,
agricultural sciences, medical devices, and information technology. Our legal
services include assistance on mergers and acquisitions, joint ventures,
corporate finance, development and research agreements, compliance audits, and
privacy matters.
Our Food, Drugs, Medical Devices, and Cosmetics practice focuses on counseling
corporations and individuals on all aspects of the US Food and Drug
Administration (FDA) regulatory and corporate matters, primarily in the areas of
pharmaceutical, medical device, tobacco, and food regulation, as well as related
corporate transactional activities. We have represented clients before the FDA,
the US Drug Enforcement Administration, state departments of agriculture, and
various state boards of pharmacy. We also have assisted clients with the
preparation and filing of numerous drug, device, and tobacco premarket
submissions and other regulatory filings, as well as defended our clients in FDA
enforcement actions, such as warning letters and consent decrees. Our
transactional experience includes negotiation and drafting of licensing, supply,
distribution, and purchase agreements related to FDA-regulated products and
pricing. Additionally, we represent pharmaceutical manufacturers on government
price reporting, compliance, and contracting matters related to the Medicaid
Drug Rebate Program, 340B, and Veterans Affairs regulatory programs.
Lawyers in our Research Triangle Park office also counsel clients with respect to
public finance transactions. Our lawyers have extensive experience in guiding
nonprofit hospital and continuing care retirement community clients through the
tax-exempt bond issue process. Our lawyers have worked on public finance
transactions that, in the aggregate, total over several billion dollars.
