TRANSACTIONS  INVOLVING FDA-REGULATED COMPANIES
OR PRODUCTS
FDA Regulatory Strategy and Freedom-to-Operate ("FTO") Validation
(to Support Investments and Financings)
    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 ...
FDA Legal Services --  for the life of a Life Sciences company
Product/Issue Specific
FDA Legal Services
Ad Hoc
FDA Legal Services
Links to My Other Services
Life Cycle
FDA Legal Services
© 2014  Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Michael A. Swit