transactional due diligence

FDA Regulatory Counsel combines go-to national subject matter expertise with the corporate transactional experience of hundreds of middle market life science deals. Our attorneys perform practical, business-minded diligence for M&A, corporate finance, and venture capital and private equity, drawing on our familiarity with current market standards and a deep well of industry history. Working side by side with your team or advising behind the scenes, we understand that each transaction comes with its own ecology, and deliver insight accordingly. 

Our lawyers work among the ranks of some of the most prolific health care lenders and investors in the country, and provide regulatory expertise for law firms without in-house FDA counsel. With advanced degrees and decades of experience, FDARC has the insight necessary to advise on the risk and mitigation of compliance issues. We are also available to provide post-closing oversight and sit as advisory board members.


Healthcare and life science compliance is high stakes because the FDA is the ultimate arbiter of a product's ability to be marketed in the U.S. From regulatory posture and financial prospects to potential liability and post-deal 'compliance check-ins', expert review can mean the difference between absorbing and apportioning risk. Moreover, applying our knowledge of the intricacies of FDA law to a target company often reveals unrecognized revenue streams. Ultimately, FDARC performs pragmatic, tailored diligence enabling our clients to make the most informed business decisions.

Representative Matters

  • Provide regulatory law support for commercial finance, investment and M&A activities, including conducting due diligence, negotiating key regulatory terms, and supporting post-transaction integration activities.

Industry White Papers

FDA Regulatory Counsel provides exclusive insight and regulatory review of industries and segments, allowing potential entrants to gauge attendant risk. We track regulatory trends and commensurate market adjustments, and are able to formulate projections based on historical markers. 

Deal Diligence

Due diligence in the course of corporate transactions is fundamental to including robust regulatory provisions, including representations and warranties and affirmative compliance, notice and other post-closing covenants. Comprehensive scheduling requirements further ensure fulsome disclosures. Compliance gaps and FDA enforcement history can inform indemnification and valuation decisions in the broader deal terms.

Granular Target Analysis

FDARC conducts high level review of prospective target companies, providing clients with early insight into regulatory posture and risk factors. Targeted knowledge at this phase also allows us to recommend activism and asses the scope of ultimate engagement.   

Post-Event Review/Implementation

FDARC provides oversight mandated by post-closing covenants, such as regulatory event reporting and scheduled compliance reviews. We also implement remediation and value-enhancement measure, and provide board advisory.

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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.