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; 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 complete contract and specific clause drafting
    ♦ 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
, click here ...
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© 2014   Michael A. Swit.  
ALL RIGHTS RESERVED.

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Michael A. Swit