Mission Statement

Seeking to benefit people who design, manufacture, or regulate medical devices or pharmaceuticals, Compliance-Alliance will work to clarify the rules by presenting the latest thinking on what it takes to achieve and maintain compliance with FDA and CMS requirements.

Leadership

Nancy Singer founded Compliance-Alliance LLC to specialize in professional development for those employed in the drug and medical device industries. Previously she was the founder and the Executive Director of the Medical Technology Learning Institute, an educational entity within AdvaMed that provides training on FDA/CMS regulatory requirements. She also served as AdvaMed’s Special Counsel for FDA compliance and enforcement matters. In her role as Special Counsel, Nancy was a member of the FDA/industry working group that evaluated and suggested reforms to the FDA inspectional process. 

She then represented the industry on the working group that conceived and validated the procedures for the Quality System Inspection Technique (QSIT). She served as the industry spokesperson on the educational programs that taught QSIT to representatives of FDA and the medical device industry.

Before joining AdvaMed, Nancy was the Vice President and Executive Director of the Food and Drug Law Institute. Her career began as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. Nancy received her B.S. from Cornell University , and J.D. and L.L.M. degrees from New York University Law School. During her career, she taught food and drug law at Catholic University Law School and George Washington University Law School. She chaired the Food and Drug Law Section of the Federal Bar Association, and retired as a Commander in the United States Naval Reserve. Nancy’s email address is nancy@compliance-alliance.com.
 

Awards

While working on QSIT and the FDA/Industry Grass-Roots Task Force, Nancy received Vice President Gore’s Reinventing Government Hammer Award. She received the FDA Commissioner’s Special Citation on two occasions. 

Nancy received the Distinguished Service and Leadership Award in 2007 from the Food and Drug Law Institute.