FDACounsel.com  -- Legal Services --  for the life of a Life Sciences company

For any Life Sciences company, the nature of the critical issues they will face that arise out of the laws and regulations enforced by FDA will
relate directly to where the client stands in its own legal life cycle.  For the
start-up, FDA 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.  For the
established firm with marketed
products
, FDA legal challenges can take on a myriad of aspects, 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.  

We are poised to provide you these critical legal services to overcome FDA's challenging and multi-faceted hurdles
... for the life of your Life
Sciences company ...
                               

"LIFE CYCLE" SERVICES
"ANY TIME" SERVICES
SPECIFIC PRODUCT/ISSUE SERVICES
Wherever you may stand in the life cycle of your
Life Sciences company, we are poised to provide
the FDA legal counseling you need to maximize
your goals.  To learn more about the types of
services we 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 we have
provided to our clients over the years in those
stages.  

Some FDA legal issues arise at any time in a
client’s life cycle, particularly those issues that
relate to Transactions involving FDA-regulated
products or firms, compliance & enforcement
activities, & crisis management arising out of
FDA governed products or companies.  When
these do arise in your life cycle will impact their
handling to some degree; however, these issues
tend to require similar legal tactics no matter
when they emerge.  We refer to the legal
services relating to these issues as "Any Time"
Services.  You can find more information on on
on on these services by following these links:

You may be seeking an FDA lawyer with
specific experience with a certain type of
product (e.g., IVDs or OTC Drugs) or a
particular issue (e.g., Clinical Research or
Advertising & Promotion).  Descriptions of the
types of services that we provide that relate to
either specific types of products or distinct
major issues of interest cam be found by
following the links below:

Corporate Formation/Venture Financing

R&D/Pre-Approval

Marketed Products
Transactions

Compliance & Enforcement

Crisis Management
Drugs & Therapeutic Biologics

Medical Devices & IVDs

Clinical Research

Advertising & Promotion

Dietary Supplements & Functional Foods

OTC Drugs

Foods & Food Additives

Cosmetics

While the lists of services included on this website are not intended to be comprehensive, we hope it will help you focus on
how we 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 us 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 our usual practice arenas.

© 2004 Law Offices of Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact us @ 760-815-4762
or
mswit@fdacounsel.com