Zantac Expert Witnesses in Rhode Island

This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence. Her experience includes serving as a member of the Management Team (SVP RA) for three small companies developing novel drugs and biologics, and building and leading a product compliance organization (RA, QA and CQA) for a small biotech company, including approval of their first monoclonal antibody product, while serving in a leadership role on the Management Team. Prior to that, have led regulatory activities for several NDAs (leading to marketed products), INDs and post-marketing regulatory activities in 3 large pharmaceutical companies. She has 5 years experience in small molecule API process development and a PhD in medicinal chemistry and is a frequent contributor to various Industry programs. Specialties: All aspects of Regulatory Affairs for entire product lifecycles for small molecules and biologics, including: -IND/NDA/BLA submission management, prosecution and strategy -FDA meetings -Regulatory Liaison activities -Ad/Promo review and advising -CMC

This qualified expert is board-certified in internal medicine and has experience as a gastroenterologist. He received his BS in human biology, health and society from Cornell University before earning his MD from George Washington University. He then completed an internal medicine residency at Boston University and a gastroenterology fellowship at Boston Medical Center. This expert is active in his field as a member of several gastroenterology associations, including the American College of Gastroenterology, the Crohn's and Colitis Foundation, and the American Society for Gastrointestinal Endoscopy. He is also involved in research, having authored numerous gastroenterology publications and presented on several posters. He has formerly served as a telehealth physician for Thirdeye Health. Currently, this expert holds several positions, including a medical advisor for a healthcare startup and a gastroenterologist for a Massachusetts hospital.