Expert Consulting and Expert Witness Services

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 Expert  724034

Expert in FDA Litigation, Regulatory Compliance and Strategy & FDA Regulations


Available for your Consulting and Expert Witness Needs

Virginia (VA)
USA
Education Work History Career Accomplishments Consulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
Expert offers your company his 33 years of experience as an Attorney in the Office of the Chief Counsel of the FDA, and 8 years as a consultant to FDA-regulated industries. He provides clients with a wide-range of regulatory consulting services. He is especially forthcoming with advice and assistance on compliance matters and strategy. With his background in managing legal reviews and litigation, and clearing the FDA's regulations, Expert will be a valuable asset to your project team.

Expert received his law degree in 1968 from the Georgetown University Law Center. He immediately became a Trial Attorney for the FDA, representing the Agency in civil and criminal enforcement cases in court. He also represented the FDA in defensive and appellate litigation in court. From this position, he became the Special Assistant to the Chief Counsel where he assisted with law office management, resolved problems with staff employees and was responsible for special projects. In 1975 he became the Deputy for Regulations and Hearings. This position required him to manage the legal review and clearance of Agency regulations, the program review services, and administrative hearings. He became the Deputy Chief Counsel in 1979, a position he held for 20 years. In that position he assisted the Chief Counsel with internal management, provided legal service and advice to high-ranking FDA officials, represented the FDA in functions involving other federal agencies, and improved the process of reviewing proposed legal and regulatory actions. His final role at the FDA was as a Senior Advisor to the Chief Counsel. While there he provided consultant advice, assistance, and services concerning operations and management. He was responsible for the law office redesign and reorganization, and managed the attorney recruitment and selection program. Expert received numerous awards in his time with the FDA, such as the Commissioner's Special Citation in 1989 and 1999. He is also a member of the District of Columbia Bar Association.

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Food and Drug Administration

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Food and Drug Administration compliance

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Food and Drug Administration regulation


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland;  Frederick, Maryland;  Gaithersburg, Maryland;  Bowie, Maryland;  Richmond, Virginia;  Alexandria, Virginia;  Wilmington, Delaware;  and Lancaster, Pennsylvania.

Often requested
with this expert:

FDA Medical Device Quality Systems, Governmental...
FDA Regulations, Drugs, Cosmetics
Regulatory Compliance Auditing, Training; FDA NDA/ ANDA and...
OTC Drugs, Generic Drugs, New Drugs and General Drug...

Education:
Year   Degree   Subject   Institution  
1968   JD   Law   Georgetown University Law Center  

Work History:
Years   Employer   Title  

2006 to

 

(Undisclosed Consulting Company)

 

Senior Consultant

 

2002 to 2005

 

AAC Consulting Group/Kendle International

 

Senior Consultant

 

1968 to 2001

 

Food and Drug Administration (FDA)

 

Attorney

 

Career Accomplishments:
Licenses/Certifications

He is also a member of the District of Columbia Bar Association.

Professional Appointments

Expert received numerous awards in his time with the FDA, such as the Commissioner's Special Citation in 1989 and 1999.


Consulting Services:
Recent Client Requests:
  • Expert for consulting on Need to draft and help implement GMP and QA programs...
  • Fda medical device mock audit for consulting on Mock audit to 21CFR820.
  • Expert on FDA regulations relating to non-drug topical and transferal patches.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
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  • Expert in FDA Litigation, Regulatory Compliance and Strategy & FDA Regulations
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  • Expert in FDA Litigation, Regulatory Compliance and Strategy & FDA Regulations
  • Expert in FDA Litigation, Regulatory Compliance and Strategy & FDA Regulations.
  • Expert in FDA Litigation, Regulatory Compliance and Strategy & FDA Regulations
  • Expert in FDA Litigation, Regulatory Compliance and Strategy & FDA Regulations
  • FDA expert witness for consulting on an atypical antipsychotic..
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

 

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