REGULATORY & STRATEGIC COUNSEL

FDARC provides insightful counsel. We believe that deep knowledge of regulatory law is only the starting point. The experience to apply it in tailored ways, and a contextual understanding the quickly-evolving life sciences landscape, is what makes us a value-add partner. Ultimately, understanding real world implications - and seeing around corners - is the stuff of informed business decisions.

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Regulatory

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Commercial     

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FDARC provides practical, gold standard counsel on the FDCA and related health care laws - FTC, AKS, Stark, Sunshine Act, CPOM, HIPAA and licensing. We advise on course-of-business matters including product development, risk assessment and mitigation, registration and listing, approval and clearance, operations and cGMP, product claims, packaging and labeling, marketing, advertising and promotion with traditional and digital assets, supply chain, and FDA inspections. Should adverse events arise, we are adept at managing recalls, 483s, warning letters, and other enforcement actions. We help our clients develop strategies for handling legal issues in creative, business-centric ways and build processes that address risk and allow flexibility. We also continually monitor key evolving issues in regulation and industry practices to educate internal stakeholders and support external advocacy. 

FDARC provides cross-functional legal support where business and compliance meet. We are a resource for teams, specialists, management and leadership across verticals. Our strategic counsel extends from the day-to-day, such as commercial contracts with regulatory implications, to global matters of value maximization. To that end, we provide tailored strategies for organic growth including optimization of processes, allocation of resources, and product development, as well as those for inorganic growth through M&A and divestitures, including presentations, due diligence, negotiation, drafting and post-event integration.