Services -- Corporate Formation & Venture Financing


FDA Regulatory Strategy and Freedom-To-Operate ("FTO") Validation

   ♦  Ensuring correct regulatory pathways
   ♦  Overcoming regulatory obstacles (e.g., Hatch-Waxman Exclusivity; approval criteria)
   ♦  FDA regulatory process impact on FTO 

Due Diligence Reviews

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

Contract Drafting -- Complete Contracts/Specific Clauses

   ♦  Product development and FDA-related milestones
   ♦  Indemnification – regulatory compliance
   ♦  Regulatory-related covenants, warranties & representations 

To see presentations and articles on FDA Challenges in Corporate Formation & Financing, ...