A description of the various stages and sections of a Master Regulatory File (MRF) System. As an investigational product progresses through development key studies, decisions, regulatory communications, manufacturing progression are accumulated and necessary to reference as the NDA and MAA applications are made. Therefore MRF systems needs to preplanned and have sections to organize this information. Although this won't be discussed this organization is applicable to a well managed document management system.
Using Regulatory Master Files for Investigational Products
9 April 2014, michigan, United States
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