The Electronic Regulatory Submissions Software Solution from QUMAS delivers fully automated FDA Electronic Submissions in compliant manner. The FDA is moving towards requiring electronic submissions under FDASIA (FDA Safety and Innovation Act). With the release of the new guidance on the standards and format of electronic submissions including electronic Common Technical Document (eCTD) format, it’s a good time for organizations still using paper-based to transition to an industry standard electronic document management system (eDMS). The QUMAS Electronic Submission Solution provides template-based authoring capabilities with full metadata integration, allowing for a simplified electronic submission management process. Take advantage of the digital and electronic signature capabilities while managing all submission documents with full 21 CFR part 11 compliance, meeting all international regulatory requirements and standards.
The QUMAS R&D Solution provides end-to-end regulatory content management, by linking document creation using Microsoft Word authoring templates and management to content gathering, tracking and submissions compilation for an efficient one-stop shop for submissions lifecycle management. By combining content authoring, content management, real-time collaboration and submission management, we provide one, integrated solution for all functional R&D areas. This solution includes but, is not limited, to Regulatory Affairs, Clinical, Nonclinical, and Quality. The solution is all inclusive — there is no additional sourcing, customization or additional integration required to immediately take advantage of a complete R&D strategy out of the box.
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