For Regulated Companies

If your business falls within the FDA’s deep and wide legal footprint, you are already aware of its often-subjective and selectively-enforced compliance burdens. In addition, your products by nature stand the highest risk of being targeted in consumer liability litigation. There are also unique qualities to even the most common business dealings when you operate at the intersection of innovation and regulation – from contractual agreements to financing to supplier, customer, and contractor relationships.

DIRECT 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.

PRODUCT LITIGATION

  • Initial claim vetting – prove/disprove substantive issues
  • Develop case theory
  • Scientific and medical causation expertise
  • Expert witness
  • File, case, and IME review for weaknesses and opportunities
  • Expert medical discovery support – Depositions, Interrogatories, RFPs
  • Pipeline product risk-vetting, assessment, and advance management

Corporate

  • Due diligence for financial transactions:
    • Borrower
    • Merger
    • Acquisition
    • Investment
  • Assistance with FDA-related compliance aspects of commercial contracts, including manufacturing, sales, and distribution agreements.