For Lenders & Investors

From broad pre-deal industry questions to granular company due diligence, FDA & Medical Counsel provides business clients with the expertise needed to support informed decisions when crafting deals in FDA-regulated spaces. FDAmc provides companies with a regulatory due diligence checklist to navigate those environments by assessing compliance, regulatory framework, and business risk and implications. In addition, Dr. Borrillo can vet startup or pipeline products based on the potential success of their real-world application and markets.

Transactional Subject Matter Expertise

  • FDA due diligence on regulated companies:
    • drug
    • medical device
    • dietary supplements (nutraceuticals)
    • food and beverage
    • cosmetics
    • veterinary products
    • pharmacies
  • Vet prospective deals based on industry posture and target companies/products
  • Medical and scientific vetting of marketed and/or pipeline products
  • Review and advise on compliance posture, history and potential vulnerabilities
  • Review and advise on compliance posture, history and potential vulnerabilities
  • Assess regulatory risk in order to support informed business decisions
  • Assess product liability risk assessment and counsel on risk management
  • Advise on prospective liability from regulatory enforcement
  • Assist with negotiation of pragmatic deal terms
  • Draft credit, purchase, and other agreement language, including tailored reps and warranties
  • Advise on ancillary regulatory requirements (transfers, registrations, contracts)
  • Provide high level industry insight where regulatory and product issues affect business outcomes