Life Cycle Services

Corporate Formation & Financing

At start-up, the life sciences company faces many legal challenges.  While corporate formation, financing, and IP issues typically predominate, the astute company also realizes that tackling FDA issues -- regulatory, clinical, and quality - at the outset is vital to long-term success.  

For more information on the services we provide at this stage of the life cycle, ...

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Research & Development to Submission

As you move into preclinical and clinical development and ultimately to applying for market authorization, new legal concerns emerge in the regulatory, clinical, and quality realms.  How you tackle these  directly impacts the potential for eventual approval of your product application.  

Details on how we can help you during this journey can be found if you ...

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Marketed Products

Once on the market, an array of new regulatory and quality legal challenges emerge.  Ranging from new safety concerns to handling advertising issues to responding to FDA developments that threaten your products, we can help  ensure you overcome these hurdles and also take the proactive steps needed to maximize success.

To see how we help you in the post-approval stage with marketed products. ... 

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For presentations and articles on lifecycle management and strategy for FDA-regulated companies, ...