|
FDA Regulatory Strategy and Freedom-To-Operate ("FTO") Validation
♦ Ensuring correct regulatory pathways
♦ Product line extensions
♦ Franchise protection (non-patent)
♦ Overcoming regulatory obstacles (e.g., Hatch-Waxman Exclusivity; generic biologics)
♦ 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 -- Both comprehensive and addressing specific clauses:
♦ Product development and FDA-related milestones
♦ Indemnification – regulatory compliance
♦ Regulatory-related covenants, warranties & representations
For presentations and articles on Transactions involving FDA, click here ...
|
|
For "Life Cycle" Stages Legal
Services, Just Click on The
Related Button Below ...
|
