The objective of this contract is the production of FDA-required documentation in support of an Investigational New Drug (IND) application. This includes the development for specific vaccines of the Master File, Investigator's Brochure and compilation of an IND application including a vaccine trial protocol appropriate for submission to CBER, FDA for an IND. The contractor must also work together with other contractors performing safety and immunogenicity testing of the vaccine product or manufacturing the specific vaccine product.
