Abstract: Systems and methods of managing regulatory information are described. In one aspect, a library of submittal components is accessed. Each submittal component specifies respective submittal content. The submittal component library is queried based at least in part on information relating to a regulated product and at least one regulatory approval objective, wherein each approval objective specifies a compliance approval type and a target market in which the product is regulated. Based on the submittal component library query, a universal submittal package is generated. The universal submittal package comprises a set of submittal components for generating at least one submittal package. In another aspect, regulatory rules are accessed. The regulatory rules specify content required to satisfy at least one regulatory approval objective for at least one regulatory agency in a respective target market in which a product is regulated. A library of submittal components is built.