Susan Carter, MS, is a Senior Regulatory Science Specialist at Coté Orphan, which is a boutique full-service regulatory consulting firm that focuses on the development of orphan drugs. Ms. Carter has considerable experience not only in regulatory affairs but also in global clinical program management in both drugs and biologics. At Coté, she authors FDA/EMA orphan drug applications, FDA meeting requests/briefing packets, and IND/NDA/BLA/CTA/MAA applications. Additional responsibilities include preparing feasibility assessments and regulatory development strategies. Her industry experience includes roles in both clinical and regulatory at Pfizer, Abbott, and Schering-Plough. She attended the University of Maryland School of Pharmacy for her Master of Science degree.