Jeremy White is responsible for drug substance and drug product analytical method development, commodity evaluations, method validation, formulation support, method transfers, and support of the eCTD modules and sections for all ANDA, NDA and ANADA submissions.
Dr. White has over 15 years combined experience in pharmaceutical method development and analytical chemistry. He received his doctorate degree in Analytical Chemistry from The Ohio State University, in Columbus, Ohio. He started his pharmaceutical career working with branded and generic products at Mylan Pharmaceuticals, where he developed analytical methods for numerous approved ANDA applications. Dr. White has experience and expertise in method development and formulation support of immediate, modified, and controlled-release tablets, capsules, oral solutions, suspensions, topical creams, gels, and otic solutions.
Since joining Sovereign in 2013, Dr. White has led a team of development scientists in the successful development and validation of over 60 analytical methods that support approved ANDA, ANADA, NDA and OTC products. He serves as the main contact for analytical support at Sovereign and is responsible for post-submission communication with the FDA for all chemistry related questions. He has improved the technical quality and through-put of method development activities with his leadership, experience and strong technical writing skills. Jeremy and his team strive to develop quality, robust and economical methods in support of all Sovereign products from early development to commercialization.
Current role