Services -- Transactions Involving FDA-Regulated Products


FDA Regulatory Strategy and Freedom-to-Operate ("FTO") Validation (for Investments and Financings)

   ♦ Ensuring correct regulatory pathways
   ♦ Product line extensions
   ♦ Franchise protection (non-patent)
   ♦ Overcoming regulatory obstacles (e.g., Hatch-Waxman Exclusivity; approval criteria)
   ♦ FDA regulatory process impact on FTO 

Due Diligence Review

   ♦ Assessing FDA-related strengths and weaknesses of targeted companies/products
   ♦ FDA compliance issues presented by target transactional parties
   ♦ FDA approval status assessments 

Contract Drafting -- Comprehensive and Specific Clauses

   ♦ Product development and FDA-related milestones

   ♦ Indemnification – regulatory compliance

   ♦ Regulatory-related covenants, warranties & representations

For articles and presentations on transactions involving FDA-regulated products and companies, ...