fda compliance

product approval

commercialization

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regulatory due diligence

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litigation support

government affairs

The Food & Drug Administration regulates 25% of all consumer products sold in the U.S. every day. 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.

services

due diligence

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 implementation, change management, oversight and board advisory.

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regulatory compliance

For regulated companies, FDARC advises directly on product approval, pathways to commercialization, regulatory filings, pre-submission activities, registration, supply chain, import, compliance best practices and response to FDA concerns. We can also liaise with the Agency on regulatory communications and enforcement activities when clients are faced with inspections, recalls, 483s, warning letters and other potential violations. We draw on our historical relationship with FDA to work together in a mutually beneficial way. Ultimately our goal is to reduce a client's regulatory burden at each turn.

litigation support

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.

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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.

we invite you to learn more about fdarc