Ms. Dunn is an international regulatory expert and has over 30 years of consulting experience. Her expertise includes regulatory strategy and implementation and GLP compliance. As a regulatory consultant, Ms. Dunn has reviewed and written numerous IND, NDA/BLA, and CTA/CTR packages, participated in FDA and ex-US regulatory meetings, and provided strategic regulatory advice for global development programs. She has successfully negotiated expedited regulatory packages with the FDA including Breakthrough therapy designations, and has written numerous Orphan Drug Designation packages. Ms. Dunn currently serves as an US Agent across all Division of CBER and CDER, and maintains excellent working relationships with the FDA. In addition, she is an expert in GLP implementation and interpretation, and is an author on the RAPS chapter on GLP compliance. Ms. Dunn has strategic regulatory expertise in OTC and Rx pharmaceuticals, cosmetics, biopharmaceuticals, and devices. She was a founding majority partner at Aclairo Pharmaceutical Development Group, Inc. and a consultant at Milestone Biomedical Associates, SRA Life Sciences, Inc. and an independent consultant prior to the formation of Dunn Regulatory Associates, LLC. Prior to her consulting experience, Ms. Dunn worked at Covance and EPL, Inc. in project management and project coordination roles.