#21: Successful Drug Development: Best Practices for Drug Development Planning, Agency Interactions, and Regulatory Document Writing
- Executive Director, Regulatory Consulting and Submissions
- INC Research, United States
Elaine B. Taylor is Global Head of Regulatory Consulting and Submissions at INC Research responsible for leading a global team of regulatory professionals providing consultation, development, and management of regulatory interactions and submissions for sponsors. With over 25 years of experience in pharmaceutical drug development, she has extensive knowledge of ICH and CTD guidelines, 505(b)(1), 505(b)(2), and ANDA drug programs. Her main focus is to provide strategic advice and manage the regulatory aspects of drug development for sponsors from pre-IND stage to NDA submission.