Ms. Spigelmyer has over ten years of experience in Regulatory Affairs Consulting & Quality Assurance. Her experience includes managing the development of new drug products through the pre-IND, IND, and NDA processes to support marketing approval by FDA. She has expertise in CMC aspects of drug development including technical writing. Ms. Spigelmyer has written countless FDA meeting requests, background packages, orphan drug designations, fast track designations, pediatric rare disease designations, Module 2.3 & Module 3 documents. Ms. Spigelmyer has a B.S. in Chemistry.