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FDARC FOR REGULATED COMPANIES

FDA Regulatory Counsel provides strategic legal and commercial guidance to FDA-regulated consumer products companies. Our knowledge and experience allow us to steward day-to-day compliance, handle complex challenges and strategize commercial and regulatory success.

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REGULATORY & COMMERCIAL COUNSEL

FDA Regulatory Counsel provides insightful regulatory and commercial counsel for industry clients. Because we understand that, ultimately, Regulatory Means Business, our dual focus is compliance and strategic development. Our experience working with regulated companies and on M&A transactions affords us unmatched perspective on quality programs, business initiatives and growth strategies. 

At its core, there is no substitute for deep knowledge of regulatory law. Compliance requires a broad understanding of not only statutory requirements but also myriad complex (often arcane) regulations, policies, guidances, enforcement priorities and industry standards. Moreover, the regulatory landscape is constantly evolving. As technology pushes innovation forward, FDA oversight expands. Understanding the Agency's position is critical to making informed business decisions.

Regulatory

 

 

 

 

 

 

 

Commercial     

FDARC provides gold standard counsel on compliance with the federal Food, Drug & Cosmetic Act. We advise on course-of-business matters including registration and listing; approval and clearance; manufacturing and QSR; claims and labeling; marketing, advertising and promotion; supply chain and distribution; and FDA inspections. Should adverse events arise, we are adept at managing responses to recalls, 483s, warning letters and enforcement actions and liaising with in-house regulatory professionals, outside counsel and regulators. Operationally we develop, implement and harmonize policies and procedures facilitating regulatory activities that are both effective and efficient. 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 integration. 

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LITIGATION

FDA Regulatory Counsel handles, manages and supervises a wide range of domestic and international disputes involving regulated consumer products. We are barred in multiple jurisdictions nationally and experienced in all stages of litigation including initial strategy, motions practice, discovery and negotiations. We add insight on complex compliance issues by providing subject matter expertise. FDARC is also experienced in handling DOJ enforcement actions for FDA-regulated clients.

 

Representative Matters

  • Apply regulatory insight to global issues of fact and law in national MDL proceedings.

  • Negotiate resolution of individual plaintiff matters for consumer products clients.

  • Advise on and conduct compliance-related discovery, including drafting interrogatories, taking depositions, and interpreting information and documents.

  • Support expert witness testimony.

  • Inform motions practice and trial proceedings on FDA-related issues.

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ADVOCACY & GOVERNMENT RELATIONS

FDA Regulatory Counsel's Washington, DC practice provides subject matter expertise to government relations teams. As regulatory lawyers, we are uniquely able to educate legislators and regulators on developing laws, regulations, public policy and enforcement guidelines.

FDARC is particularly focused on innovative life sciences and emerging industries. We have counseled individual lawmakers and committees on the precedents and implications of new regulations, including:

 

  • Medical device 510(k) overhaul

  • Dietary Supplement Health and Education Act (DSHEA)

  • 503B Compounding Pharmacy Act

  • Advertising, off-label claims and scientific exchange policies

  • Mobile and TeleHealth development

  • Food Safety Modernization Act (FSMA)

  • Tobacco Deeming Rule (e-cigarettes/vape)

  • 2018 Farm Bill

  • Hemp, CBD and cannabis policy

Representative Matters

  • Liaise with government and regulatory bodies, including FDA, on regulated products, scientific information, formal and informal inquiries, and legislative and regulatory policies.

  • Draft comments and responses to regulatory dockets, proposed laws and regulations, FDA guidance documents, and industry group policy positions.

  • Inform and shape advocacy before Congress, FDA, and other federal and state bodies and agencies with respect to existing and emerging regulatory policies.