About Us

C. Nielsen Consulting (CNC), was founded in 2005 by Mr. Carl R. Nielsen, a 28 year veteran of the U.S. Food and Drug Administration, (FDA). He spent his last 6 years of his FDA career, as Director of FDA's Division of Import Operations. That Division is responsible for implementing national FDA import policies, procedures and enforcement strategies, and coordinating border activities with US. Customs Border Protection and other federal border agencies, such as USDA. During his career Mr. Nielsen served as an FDA inspector/investigator, a resident in charge, a supervisor of the Baltimore import group, a compliance officer in the field and FDA headquarters; a senior special agent with FDA's Office of Criminal Investigations, and finally a senior executive manager with FDA's Office of Regulatory Affairs. Mr. Nielsen has extensive compliance expertise and paralegal experience in developing and supporting FDA civil and criminal casework, especially in areas related to foods, drugs, biologics and medical devices.

Since his retirement in 2005 he has been providing litigation support and consulting for the legal profession, and regulatory consulting and training services for foreign and U.S. industries, trade associations, foreign government officials and advocacy groups. In 2007 he testified before two subcommittees in the U.S. Congress as a subject matter expert in FDA import operations, was interviewed and quoted by nation written press several times, and appeared on radio and major nationwide newscasts related to FDA regulated imports and operations. He has conducted training for the foreign medical device industry, advocacy groups, and foreign government officials. Mr. Nielsen is an active member with the American Association of Exporters and Importers (AAEI) and the Association of Food and Drug Officials (AFDO).

The combination of Mr. Nielsen's expertise with those in a network of associated professionals with extensive FDA and USDA technical and regulatory experience, allows CNC to rapidly analyze and identify relevant FDA requirements, and to identify and execute next steps to ensure compliance with FDA requirements and access to the U.S. market.