The move toward all-electronic submissions and the stringent FDA submission requirements pushes life sciences companies to adopt a disciplined approach toward the authoring and review of submissions documents. Companies that do not begin to create and publish submissions-ready documents in the early stages of the clinical study process will unquestionably face delays in the submissions process and possibly suffer adverse effects from delayed approval and potentially lose profits as products take longer to get to market.
MasterControl Inc.’s Submissions Locker is an indispensable tool that can be utilized throughout a submission’s lifecycle. The Submissions Locker provides a secure environment that is accessible to any publishing tool preferred by the user. The Submissions Locker works in tandem with MasterControl’s enhanced Submissions Gateway to help users better prepare and control electronic submissions to regulatory agencies by supporting a full lifecycle for creating submissions.