The submission process begins with early stage discovery research and the subsequent IND. Building on this initial scientific data and FDA authorization, the dose-ranging study, human trials, and a pharmacoeconomic study follow. Results from these studies, as well as CMC manufacturing and quality processes, and any studies that have been done by external research organizations, are combined into the NDA. If documents have not been organized and stored within a secure document management system, the data that must be complied, reviewed, and organized can become a labyrinth of confusion and revision. The sheer volume of data and reports from CROs and Principal Investigators that must be reviewed in order to develop a meaningful regulatory strategy for securing approval makes it easy to miss important information.
MasterControl collaboration and document approval software can help organize and manage the study data and results as they come in, enabling the submission to be developed in parallel with the studies. MasterControl also provides out-of-the-box solutions to help paper-based companies organize the necessary documents required for FDA approval.
MasterControl automates pharmaceutical GxP processes to improve efficiency and speed time to market. Processes include:
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