Preparing for a drug application is a complex and time-consuming process. Many Contract organizations have insufficient systems for creating and approving responses, and sharing them with sponsors. This can delay time-to market for new drugs and tighten the profit window of the sponsor organization (and so the contract organization). Conventional submission management solutions are not enough — they lack the integration to unify document and submissions management into one seamless whole.
The QUMAS R&D Solution addresses this gap 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.
For more information, download the following webinars:
- Managing Successful Electronic Submissions to the FDA
- Implementing End-to-End Submission Management, From Content Creation to Publishing
- Electronic Archiving for Regulatory Content – Industry Expert Panel
- Regulatory Content and Submission Management in the World of SharePoint