Transactional Due Diligence

FDARC assesses compliance/risk posture for middle market buy and sell side deals in commercial finance, investment and M&A. We conduct and field due diligence, negotiate key regulatory terms and support post-transaction integration activities.

Mission

Origins

FDA Regulatory Counsel was founded in 2008 by the former chair of an AmLaw 100 FDA Life Science Practice Group with the progressive idea that every stakeholder in the life science industry should have access to high level FDA subject matter expertise.  Because the pool of experienced counsel is shallow, and the FDA's footprint broad, there is great efficiency in plugging in knowledge on demand.

Over a decade later, FDARC remains the nation's premier specialty regulatory law firm.

FDA Regulatory Counsel combines go-to national subject matter expertise with the transactional experience of hundreds of middle market deals. Our attorneys perform business-minded diligence for M&A, corporate finance, VC and PE, drawing on our familiarity with current market and a deep well of industry history. We are experienced on buy and sell side transactions, and have considerable experience working on initial divestitures with original founders.

 

As regulatory specialists, we also understand that each transaction comes with its own ecology and we deliver insight accordingly; we can work alongside your team or advise behind the scenes. We advise 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-event oversight and sit as advisory board members.

 

Compliance is high stakes because the FDA is the ultimate arbiter of a food, cosmetic or health 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.

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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 robust regulatory provisions including representations and warranties, 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 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.