Christine Berardi, Ph.D.

Senior Consultant

Christine Berardi is a scientific and regulatory affairs professional with over 10 years of industry experience supporting integrated product development of both small and large molecules, including cell and gene therapies. Her focus is on regulatory strategy from identification of lead compound through later stages of development, supporting both domestic (FDA) and global (European, Canadian) development programs. Christine has a broad background in regulatory communications, including managing and authoring Investigational New Drug Application (IND)and Clinical Trial Application (CTA) submissions, preparing, and representing Sponsors at FDA meetings, such as pre-IND, End of Phase, Type C, and Advisory Committee meetings, and management of electronic FDA submissions. Her experience spans many indications such as pain, gastrointestinal, ophthalmology, and rare diseases. Christine has a Ph.D. in Biochemistry and Molecular Biology from Thomas Jefferson University and a B.S. in Biochemistry from Lebanon Valley College.