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 for a complete description).
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/Clinical 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. 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.