Profile
Christopher E. Gottfried focuses his practice on health care and FDA matters, as well as administrative and regulatory matters. Christopher represents clients such as pharmaceutical companies, clinical research organizations, nationwide pharmacies, cosmetic manufacturers and distributors, drug and cosmetic retailers, medical device manufacturers, drug and device distributors, large physician practice groups and hospital chains, compounding pharmacies, food manufacturers and distributors, ambulatory surgical centers, and home health agencies. He has experience working with numerous federal and state governmental agencies, and handles matters concerning fraud and abuse, drug and device development and regulation, clinical research, cosmetic product development and regulation, health care privacy including HIPAA, health care hospital and practitioner licensure and certificate of need, and various medical billing laws and regulations.
Christopher’s experience includes working with health care organizations to navigate the various clinical trial regulations from product inception through post-product marketing. Christopher has assisted various pharmaceutical, medical device, dietary supplements, and cosmetic manufacturers, distributors, and retailers in their clinical trial and regulatory matters.
Christopher also handles various regulatory matters for a wide range of health care entities. From data privacy and HIPAA to fraud and abuse, Christopher has assisted organizations of various sizes through complex health care regulatory schemes.
Prior to entering law, Christopher worked in research institutes both in the United States and abroad in cancer and internal medicine research.
Concentrations
- Health care fraud and abuse, including the Anti-Kickback Statute and Stark Law compliance
- Life Sciences
- Health care government investigations and defense
- Life Science, cosmetic, food, and health care transactions
- HIPAA and health privacy & security
- Life sciences, cosmetic, and food regulatory and compliance from product inception to retail
- FDA and MoCRA regulatory, compliance, and enforcement
- False Claims Act
- Life Sciences and health care private equity
Capabilities
Experience
- Developed clinical research material to nationwide pharmaceutical company.
- Assisted in drug and device product development through FDA approval.
- Handled FDA market withdrawals and recalls for drug and dietary supplement companies.
- Handled response and investigation of HIPAA security incident of nationwide health care provider.
- Set up global clinical trials for pharmaceutical start-up.
- Handled internal Anti-Kickback Statute and Stark Law internal investigations for physician practice groups.
- Assisted in pharmacy and compounding pharmacy licensure.
- Obtained Florida approval for use of a novel venipuncture device.°
- Represented a South Florida university in health care compliance matters.°
- Appealed reduction to disproportionate share hospital funding on behalf of a large public hospital.°
- Handled federal investigations involving compounding pharmacies, large physician groups, and skilled nursing facilities.°
°The above representations were handled by Mr. Gottfried prior to his joining Greenberg Traurig, P.A.
Recognition & Leadership
- Member, Personal Care Products Council (PCPC)
Credentials
-
J.D., University of Miami School of Law, 2012
- Member, Law Journal
- B.S., Cell and Developmental Biology, Purdue University, 2008
- Florida
- District of Columbia