FDA Legal Services--for the life of a Life Sciences company

Life sciences companies face legal issues that arise in an array of circumstances ...

Many legal challenges relate to where they are in their company's life cycle -- start-up, development, or mature with marketed products.


Other legal hurdles relate to the type of product involved or the issue presented under the company's evolving circumstances.


And, in the case of transactions, FDA enforcement, and crisis management, the need for experienced regulatory counsel can arise at any time.


No matter when or why an FDA-related issue confronts you or what it relates to, you need experienced counsel. More information on the services I provide can be found below.  And, if your issue falls outside of my areas of experience, I will refer you to counsel that can help you.  

Product- and Issue-Specific Services

You may be seeking FDA legal expertise to tackle a challenge relating to a certain type of product (e.g., Drugs & Biologics, Medical Devices &  IVDs, Food Additives or OTC Drugs) or a particular issue (e.g., Clinical Research or Advertising & Promotion).  


Our product- and issue-specific services include focusing on:


  • Drugs and Therapeutic Biologics
  • Devices & IVDs
  • Clinical Research
  • Advertising & Promotion
  • Food & Additives
  • Dietary Supplements & Functional Foods
  • OTC Drugs
  • Cosmetics

Ad Hoc Services

Some FDA legal issues can arise on an ad hoc basis at any time in a client's life cycle, particularly those relating to Transactions,  or Enforcement involving FDA-regulated products or firms, or those issues demanding Crisis Management expertise.  

Our ad hoc legal services include 

handling issues relating to:


  • Compliance & Enforcement
  • Transactions
  • Crisis Management    

Life Cycle-Related Services

Wherever you may stand in the life cycle of your Life Sciences company -- from Corporate Formation/Financing to R&D to Marketed Products,  you will face challenges that often are unique to that stage of your firm's evolution.  We provide the FDA legal counseling you need to maximize your goals at each point in your life cycle.


For more information on services that arise at distinct points during the life cycle, 

follow the links below:


  • Corporate Formation & Financing
  • Research & Development
  • Marketed Products

Representative Engagements

And, because details on services can lack context, by clicking below, you can access 

examples of representative services I have provided clients over the years.