CCS ASSOCIATES, INC.

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This project provides administrative, technical, informatics and regulatory resources and expertise to support the regulatory affairs functions for the Division of Cancer Prevention (DCP) chemopreventive agent development program. The regulatory contactor develops and implements procedures for accessing, reviewing, and compiling scientific, safety, and clinical data for possible inclusion in lNDs and other regulatory submissions. Regulatory submissions are made in accordance with FDA regulations, ICH (International Committee on Harmonization) guidelines, and NIH, NCI, and DCP requirements and other relevant regulations, laws, and guidelines. Primarily this task involves the preparation and submission of Investigational New Drug Applications (INDs) to the U.S. Food and Drug Administration. Submissions will also include Drug Master Files (DMFs), New Drug Applications (NDAs), providing adverse event data for development of the Investigator's Brochures by the Technical Support contractor, Common Technical Documents, and other documents required by FDA regulations. For multinational research efforts supported by DCP, the contractor may be directed to prepare submissions to international regulatory bodies.