fda due diligence
The U.S. Food & Drug Administration regulates 25% of all consumer products on the market today. Each must comply with a complex set of regulations governing their registration, approval, manufacture, distribution, packaging, labeling, advertising and recordkeeping, among others. Moreover, the FDA regularly inspects regulated companies and products to ensure ongoing compliance, and maintains continuing control over their operations. At FDARC, we say 'regulatory means business' because of the high stakes of healthcare and life science compliance.
Subject matter expertise in FDA law is concentrated in a relatively small field of experienced attorneys, most of whom reside behind the walls of large law firms. As the former head of an AmLaw 50 regulatory practice, FDARC's founding partner identified the need for clients to capture expertise on an as-needed basis without prohibitive overhead, and established FDA Regulatory Counsel. Over a decade later, we remain the nation's premier regulatory boutique bringing FDA expertise directly to transaction teams, regulated businesses, law firms and industry advocates.
medical device + diagnostics
cosmetics + aesthetics
tobacco + vape
cannabis + cbd
FDA Regulatory Counsel provides on-demand due diligence and life science expertise to law firm corporate groups, lenders and investors weighing risk and reward in middle market FDA-regulated transactions. As ad-hoc members of the deal team, either behind the scenes or in direct capacity, we expand the scope of our clients' capabilities. We are also available to provide post-closing oversight and board advisory on a case-by-case basis.
For regulated companies, FDARC advises directly on compliance matters and maintains an exclusive network of consultants providing all manner of regulatory services. We counsel on internal projects including best practices, preparing for financing or acquisition, and responding to FDA concerns. We also liaise externally with the Agency when clients are faced with inspections, recalls, 483s, warning letters and other potential violations, drawing on our historical relationship with FDA to resolve matters in a mutually beneficial way.
FDARC provides subject matter expertise for legal teams across the country in litigation stemming from DOJ enforcement and in civil proceedings. We apply regulatory insight to global case issues, advise on and conduct compliance-related discovery, support expert witness testimony, and inform motions practice and trial proceedings on FDA issues.
advocacy + regulatory affairs
For all stakeholders in FDA-regulated industries, FDARC brings subject matter expertise to government relations teams as they educate legislators and regulators. We have successfully advocated for clients on a wide variety of developing laws, regulations, policies and enforcement guidelines, including the Dietary Supplement Act, the medical device 510(k) clearance process, MHealth Guidance, drug advertising and off-label communications, the 503B Compounding Pharmacy Act, the Tobacco Deeming Rule (e-cigarettes/vape) and, most recently, CBD and cannabis policy.