IND Preparation

Global BDI’s Regulatory Affairs group can oversee the design, implementation and monitoring of the necessary small molecule or biologic studies to be included in an IND enabling program. We review data, write individual reports and compile data into FDA acceptable submissions. Our team will write the Investigator Brochure and Phase I protocol as part of the IND or other regulatory submission to allow the commencement of first-in-man studies.

Global BDI publishes high-quality paper or eCTD (electronic common technical document) format submissions quickly and efficiently.