compliance + enforcement matters

Every company marketing FDA-regulated products or providing compounding pharmacy services in the U.S. must comply with a complex set of regulations governing most aspects of business operation, including:

Moreover, the Agency 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.
FDA Regulatory Counsel has broad knowledge and deep understanding of the statutes, regulations, guidance, policies, enforcement practices and industry standards that affect the development and commercialization of FDA-regulated products. And critically, with decades of experience in Washington, we have a facility with the U.S. life science and regulatory environment that is unmatched. We also continuously monitor, review and analyze overt and nuanced developments to keep abreast of regulatory and industry trends affecting clients.
Our goal is to reduce each client's regulatory burden every step of the way by providing experienced, practical legal guidance. We advise clients of all stages on product approval and commercialization, compliance best practices and response to FDA enforcement actions. We also work directly with FDA inspectors, District Offices, and Silver Spring on inspections, recalls, 483s, warning letters and other potential violations. Drawing on our knowledge of FDA law and long-standing relationship with the Agency, we have been able to resolve client matters in mutually beneficial ways.
Representative Matters
  • Develop and provide strategic legal advice on FDA regulatory pathways to market for drugs, biologics, medical devices, diagnostics, dietary supplements, aesthetic treatments, cosmetics and veterinary products.
  • Provide legal counsel regarding FDA and FTC laws, statutes, regulations and guidance on on- and off-label issues, including sales-vertical advertising and labeling requirements as well as medical affairs-vertical promotion and scientific exchange rules.
  • Review client materials and advise on product claims, advertising and labeling statements, online and print promotional materials, IFUs, warnings and substantiation requirements.
  • Counsel clients on post-market compliance including manufacturing and quality systems, reporting, product modifications, complaint handling and field actions.
  • Advise clients and interact with FDA on potential enforcement matters including recalls, inspections, 483s and responses, warning letters, untitled letters, strict liability, and DOJ involvement.
  • Assist in the development and implementation of effective compliance programs, policies, standard operating procedures and client training relating to the operations and sales of FDA-regulated products.

  • Identify and analyze risks and mitigation strategies associated with FDA law.

  • Identify and advise on business enhancement opportunities available within regulatory laws. 

  • Support grant funding applications.

  • Provide regulatory counsel to start ups and incubators funded by private equity and angel investors.

  • Function as Acting GC for smaller and in-transition life science companies.

FDARC advises clients in both established and innovative growth industries, and in connection with civil litigation and government advocacy on matters involving FDA law and policy.
  • Labeling
  • Marketing
  • Advertising
  • Promotion
  • Warnings
  • Event reporting
  • Recalls
  • Registration
  • Clearance/Approval
  • Manufacturing
  • Supply chain
  • Distribution
  • Product claims
  • Packaging
more details? 

regulatory means



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© 2020  by FDA Regulatory Counsel LLP


This site is not intended to be legal advice. Contacting the firm or reading the materials on the site does not create an attorney-client relationship. No confidential information should be sent over the internet. Past results do not predict future outcomes as each situation has to stand on its own. Melissa Gilmore is licensed to practice law in the District of Columbia, New York (inactive), and California (inactive). Donato J. Borrillo is licensed to practice law in Ohio.