| FDC Services, LLC International Clinical/Regulatory Affairs Compliance & Quality Systems |
About FDC Services - Global Services, Austin, Texas
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FDC Services has been providing executive consulting services to the medical
products industries since January 2001. The federal Food, Drug, and Cosmetic
(FDC) Act is the basis for US FDA Regulations. FDC Services provides numerous
services to help companies understand, comply with, and navigate the complexities
of FDA requirements. We can help you to achieve approvals, handle clinical studies,
improve quality systems compliance, and negotiate with FDA. Additionally, FDC
Services offers several other services including; international regulatory affairs,
compliance, quality systems, project management, and sterilization science. (See
our Services Link for a complete description).
David C. Furr and Dee A. Furr are the principal consultants. David has over 28 years
of US and International experience, including biological products, pharmaceuticals,
medical devices, and In-Vitro diagnostics. His industry experience includes several
years of work at the Director and Sr. VP level for significant medical products
companies, with responsibility for areas such as Compliance, Quality, Regulatory,
International Regulatory, and Clinical Affairs. As a member of Executive
Management Boards in multiple industry roles, he is familiar with the concerns and
challenges facing his clients' total business and how Quality and Regulatory can
effectively interact with Sales & Marketing, Product Development, Operations, New
Business Development, Finance, and Legal Departments.
Dee A. Furr has over 10 years of experience in medical device Clinical and
Regulatory Affairs including several years of management responsibility at J&J. She
has written IDE submissions, protocols, clinical summaries, and participated in FDA
BIMO inspection activities. Dee's industry experience includes participation in
global management boards and committees, US and International clinical affairs,
contracts, and management of CRO's, monitoring programs and sites.
FDC Services clients include major drug and medical device corporations, as well as
several small and mid sized companies. Since FDC Services was established, the
company has worked on numerous complex projects of both a short and long term
nature. Companies using FDC Services include several orthopedic implant
manufacturers, a drug coated coronary stent manufacturer, two In-Vitro diagnostic
companies, two vascular device companies, dental, pharmaceutical companies, and
a major Quality/Regulatory/Clincal Affairs Consulting enterprise and many others.
FDC Services stands ready to fill your needs too! Please feel free to contact us for
further information on services, rates, availability, and associates.
products industries since January 2001. The federal Food, Drug, and Cosmetic
(FDC) Act is the basis for US FDA Regulations. FDC Services provides numerous
services to help companies understand, comply with, and navigate the complexities
of FDA requirements. We can help you to achieve approvals, handle clinical studies,
improve quality systems compliance, and negotiate with FDA. Additionally, FDC
Services offers several other services including; international regulatory affairs,
compliance, quality systems, project management, and sterilization science. (See
our Services Link for a complete description).
David C. Furr and Dee A. Furr are the principal consultants. David has over 28 years
of US and International experience, including biological products, pharmaceuticals,
medical devices, and In-Vitro diagnostics. His industry experience includes several
years of work at the Director and Sr. VP level for significant medical products
companies, with responsibility for areas such as Compliance, Quality, Regulatory,
International Regulatory, and Clinical Affairs. As a member of Executive
Management Boards in multiple industry roles, he is familiar with the concerns and
challenges facing his clients' total business and how Quality and Regulatory can
effectively interact with Sales & Marketing, Product Development, Operations, New
Business Development, Finance, and Legal Departments.
Dee A. Furr has over 10 years of experience in medical device Clinical and
Regulatory Affairs including several years of management responsibility at J&J. She
has written IDE submissions, protocols, clinical summaries, and participated in FDA
BIMO inspection activities. Dee's industry experience includes participation in
global management boards and committees, US and International clinical affairs,
contracts, and management of CRO's, monitoring programs and sites.
FDC Services clients include major drug and medical device corporations, as well as
several small and mid sized companies. Since FDC Services was established, the
company has worked on numerous complex projects of both a short and long term
nature. Companies using FDC Services include several orthopedic implant
manufacturers, a drug coated coronary stent manufacturer, two In-Vitro diagnostic
companies, two vascular device companies, dental, pharmaceutical companies, and
a major Quality/Regulatory/Clincal Affairs Consulting enterprise and many others.
FDC Services stands ready to fill your needs too! Please feel free to contact us for
further information on services, rates, availability, and associates.