Why FDAmc

FDA & Medical Counsel provides on-demand legal, medical and scientific expertise in direct compliance, litigation and transactional settings. We count among our clients a diverse portfolio of FDA-regulated companies, law firms, lenders, and investors in the medical device, drug, pharmacy, dietary supplement, cosmetic, and veterinary products industries. Instantly expand your own capabilities in a practical way, by accessing a deep bench of expertise on an as-needed basis – without overhead or over-hiring.

COMPLIANCE

  • Interaction with FDA on all compliance issues
  • Inspection preparation and assistance
  • Form 483 and warning letter response and representation
  • Recall management and intervention
  • Adverse event reporting
  • GMP/QSR manufacturing requirements
  • Post-marketing quality control
  • Recordkeeping requirements
  • Medical Science Liaison
  • Medical Affairs
  • Labeling and product claims counseling
  • Marketing and promotion regulations
  • Off-label issues
  • Substantiation – scientific evidentiary requirements
  • Ingredients, DSHEA, GRAS, voluntary and mandatory submissions
  • Product formulation
  • Disclaimers
  • Product Review and Classification processes
  • 510(k), de novo, PMA
  • Device modifications
  • 503A/503B Compounding Quality Act
  • OTC compliance
  • Establishment registration and listing
  • Labeler and product NDC codes
  • Import assistance, import alerts, and border detention
  • Assessment and remediation of enforcement and liability risks.
  • Assistance with FDA-related compliance aspects of commercial contracts, including manufacturing, sales, and distribution agreements.

CORPORATE TRANSACTIONAL

  • FDA due diligence for health care transactions
  • Vet prospective deals based on industry posture and target companies/products
  • Review and advise on compliance history and potential vulnerabilities
  • Assess regulatory risk in order to support informed business decisions
  • 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)
  • Advise on prospective liability from regulatory enforcement or consumer action
  • Provide high level industry insight where regulatory issues affect business outcomes

LITIGATION

  • Bring FDA subject matter expertise to matters involving FDA-regulated clients
  • Augment litigation team with FDA regulatory counsel and consulting
  • Assess strength of client position
  • Provide regulatory insight to litigation team
  • Identify regulatory issues bearing on litigation