The purpose of this support contract is to provide assistance to the Division of Cancer Prevention, NCI in regulatory correspondence and data file management of Investigational New Drug Applications to the FDA. The scope of work includes primarily the preparation of regulatory submissions, regulatory IND correspondence and administrative tracking, and safety activities related to adverse event reporting. Additional activities involve maintenance of collaborative research agreement records, coordination and documentation of regulatory meetings, document management, review of current regulatory guidance documents, and quality control SOPs.
