Ad Hoc Services

Transactions

For life sciences companies, particularly those at the start-up and developmental stages, deals demand a need for legal services.  Oft overlooked in the heat of the  deal are the FDA issues -- regulatory, clinical, or quality -- that can make or break a deal's success.  


For information on services to ensure that FDA issues do not torpedo your deal...

Compliance & Enforcement

Running afoul of FDA's requirements can trigger the agency to aim its vast arsenal at you.  Whether an inspection or warning letter or court proceedings ranging from seizures to criminal prosecutions, FDA enforcement action, if not addressed promptly and properly, can cripple even established firms.


We help ensure that firms facing FDA's compliance arm respond in a manner that maximizes the chances for a successful outcome.  For details on our Compliance and Enforcement services ... 

Crisis Management

Crises involving FDA-regulated products arise in many ways.  Some are product-related such as food contaminated with listeria or e coli.  Others are systems oriented, as when a firm severely deviates from Good Manufacturing Processes.  


Regardless of the source, responding to a crisis involving FDA requires experienced counsel.  To see our services aimed at managing an FDA crisis ...