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REGULATORY MEANS BUSINESS
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FDARC FOR PRIVATE EQUITY & COMMERCIAL LENDERS
FDA Regulatory Counsel provides regulatory due diligence, compliance advice and value enhancement strategies from pre-deal summaries to due diligence to post-event integration. We advise on M&A activities with initial founders and management teams structured as acquisitions, divestitures, mergers, investments and joint ventures. Critically, our experience allows us to understand that each transaction comes with its own ecology and deliver insight accordingly.
PRE-EVENT INSIGHT
FDA Regulatory Counsel conducts high level diligence on prospective target companies to provide early insight on regulatory posture and risk factors. Target knowledge at this phase also allows us to recommend potential activism and asses the scope of engagement.
FDARC also diligences industries and products, allowing potential entrants to gauge risk. Additionally, we constantly track regulatory trends and commensurate market adjustments, formulating projections based on historical markers.
TRANSACTIONAL DUE DILIGENCE
FDARC assesses the compliance and risk posture of regulated companies for investors and lenders in middle market life science transactions.
Due diligence in FDA, AKS, Stark and HIPAA regulations is a high-stakes necessity because business is predicated on compliance. Compliance gaps and enforcement history can inform indemnification and valuation decisions in the broader deal terms.
From regulatory posture and financial prospects to potential liability and post-event compliance, FDARC's review can mean the difference between absorbing and apportioning risk. We manage M&A and debt finance deals from a healthcare perspective by negotiating key regulatory terms, drafting representations, warranties and covenants, and ensuring fulsome disclosures through scheduling.
Ultimately, FDARC performs pragmatic, tailored diligence enabling our clients to make the most informed business decisions.
POST-EVENT TRANSITION
FDARC advises on post-transaction compliance and integration activities. We are also available to counsel advisory board members from a regulatory perspective.
VALUE CREATION
Unrecognized revenue often lies within the nooks and crannies of regulatory law. At the same time, leveraging complementary and synchronistic capabilities can reduce cost and refresh a company's value creation plan. FDARC's deep knowledge and experience augment our clients' ability to maximize both.
