FDA Legal Services --  for the life of a Life Sciences company
For any Life Sciences company, the nature of the critical issues they face that arise out of the laws and regulations enforced by FDA will
relate directly to where the client stands in its own life cycle.

For the
start-up, FDA legal concerns may seem years off.  However, they can be very real relative to securing financing as astute investors
will require validation of your FDA strategy, as well as making the key decisions as to how to develop one's products.

For the
established firm with marketed products, FDA legal challenges can arise in a myriad of ways, with concerns ranging from ensuring
advertising and marketing efforts comply with both FDA and other federal/state requirements to protecting market share through line
extensions or legitimate uses of market exclusivity under the Hatch-Waxman or Orphan Drug Acts, or how to react to an adverse FDA
inspection or other enforcement action.

Wherever you may stand in the life cycle of your Life Sciences company, I can provide the FDA legal counsel you need to maximize your
For a list of representative matters I have worked on ... Click Here...
You may be seeking an FDA legal expertise to tackle a
challenge relating to a certain type of product (e.g.,
Drugs & Biologics, Medical Devices &  IVDs, Dietary
Supplements, Food & Food Additives, OTC Drugs or
Cosmetics) or a particular issue (e.g., Clinical Research or
Advertising & Promotion). Descriptions of the types of
services that I provide that relate to either specific types
of products or distinct major issues of interest cam be
found by following the links below:
Some FDA legal issues arise on an ad hoc
basis at any time in a client's life cycle,
particularly those issues that relate to
Transactions or Enforcement involving
FDA-regulated products or firms, or
Management expertise.  When these ad hoc
issues arise in your life cycle will impact
their handling to some degree; however,
these challenges often require similar legal
tactics no matter when they emerge.  You
can find more information on these
services by following these links:
Wherever you may stand in the life cycle of
your Life Sciences company -- from
Corporate Formation/Financing to R&D to
Marketed Products, I am poised to provide
the FDA legal counseling you need to
maximize your goals.  To learn more about
the types of services I provide, listed below
are the three key developmental stages of a
Life Sciences company with hot links to
more detailed descriptions of the types of
services I have provided to clients over the
years in those stages.  
The lists of services included on this website are intended to be fairly comprehensive.  I hope the services descriptions will help you focus on how I
can assist you achieve those critical business goals that any FDA-regulated company faces in its life cycle, no matter where you stand today.  And, if
your need for FDA legal counsel does not appear to fit into any of these categories of services, please feel free to contact me and we can discuss how to
best resolve your FDA legal requirements, even if that means an occasional referral to another practitioner if your concerns are outside my usual
practice arenas.
© 2014  Michael A. Swit.  


Contact me @ 760-815-4762
Michael A. Swit