Dr. Erwin joins DRA with 2+ years of experience as a Regulatory Affairs Consultant and excels in developing effective product development strategies that meet all regulatory requirements. Her expertise enables companies to navigate complex regulatory frameworks and achieve successful FDA meetings with ease.
Dr. Erwin’s experience includes FDA meeting preparation, pre-IND, IND, and NDA submissions, breakthrough therapy designation, fast track designation, orphan drug designation, and abuse liability assessment plans. Prior to joining DRA, Dr. Erwin was a Regulatory Scientist at Allucent, formerly CATO-SMS. Dr. Erwin holds a doctorate degree in pharmacology from LSU Health Sciences Center and received post-doctoral training from Harvard Medical School and Mclean Hospital. She has presented her work at conferences around the country, published on abuse liability, and discussed Scheduling issues and concerns with Senators and Representatives on Capitol Hill. Her extensive research background in preclinical pharmacology has aided her in assessing, communicating, and managing the risks related to various types of products being developed (e.g., small molecules, biologics, and devices).