Patsy Trisler provides strategic regulatory guidance and clinical compliance consulting services to medical device companies, including advising on non-clinical and clinical testing requirements for a variety of product types; preparing FDA submissions; facilitating FDA meetings; training on compliance with GCPs & FDA regulatory requirements. Patsy has been a regulatory consultant since 1991. Her regulatory affairs career started with 6 years at FDA's CDRH. Prior to that she worked as a research assistant in an NIH laboratory and attended law school part time. She attained admission to the D.C. Bar in 1983. Patsy's undergraduate degree is in biology.