Dana Dunn

Dana Dunn brings over 25 years of experience in regulatory strategy and implementation across clinical, nonclinical, and Chemical Manufacturing and Controls (CMC) to her role as CEO Advisor. Ms. Dunn is currently the Principal and founder of Dunn Regulatory Associates, a leading provider of global regulatory and scientific consulting services. During her tenure at Dunn Regulatory Associates, Ms. Dunn has provided strategic regulatory advice to solve some of the most complex regulatory challenges. She has led product development teams, successfully led and negotiated FDA and ex-US regulatory meetings, and reviewed and written over numerous INDs, CTAs, NDAs and BLAs. In addition to her work as a regulatory expert consultant, Ms. Dunn serves as an US Agent across all Divisions of the Center for Biologics Evaluation and research (CBER) and the Center for Drug Evaluation and Research (CDER), and she maintains excellent working relationships with the FDA. In addition, she is an expert in Good Laboratory Practice (GLP) implementation and interpretation and is an author on the Regulatory Affairs Professional Society (RAPS) chapter on GLP compliance. Prior to forming Dunn Regulatory Associates, she was a founding and majority partner at Aclairo Pharmaceutical Development Group, Inc., as well as a consultant at Milestone Biomedical Associates, SRA Life Sciences, Inc., and an independent consultant. Prior to her consulting experience, Ms. Dunn worked at Covance and EPL, Inc. in project management and project coordination roles. Ms. Dunn holds a Masters degree in Public Health from Old Dominion University.