Mission

We believe that pharmaceutical and medical technology companies create and market safe and effective products. We know that operating under government regulation is difficult, that product liability defense is expensive, and that adverse publicity can be crushing. We help companies change their culture to reduce the risks.

Leadership


Nancy Singer founded Compliance-Alliance LLC to help professionals employed in the drug and medical device industries to establish a culture of compliance. 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 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 LL.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 also received:

  • Distinguished Service and Leadership Award from the Food and Drug Law Institute.
  • Leadership Award in 2010 and 2014 from the Association of Food and Drug Officials
  • RAPS Special Recognition Award in 2011 from the Regulatory Affairs Professional Society
  • 100 Most Notable People in the Medical Device Industry
  • AdvaMed  Award of Merit
  • Food and Drug Law Institute Fellowship
  • Martha Van Rensselaer Scholar