In an industry shaped by ever-increasing regulation, global competition and market expectations, successful life sciences companies must bring new products to market faster than ever. Preparing for a drug application is a complex and time-consuming process. Many organizations have insufficient systems for creating and approving responses, which can delay time-to-market for new drugs and tighten the profit window before patents expire. Conventional submission management solutions are not enough — they lack the integration to unify document and submissions management into one seamless whole.
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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.
Key aspects of the solution include:
- Off-the-shelf regulatory content management system — A single, controlled repository that ensures enterprise-wide consistency and compliance
- Off-the-shelf submission management system — designed specifically for the assembly and compilation of compliant paper and electronic dossiers based on the CTD standard, and support for global electronic submission standards
- Browser-based collaborative review and authoring solution — ensures a secure, structured and controlled environment for multiple and remote collaboration
- eCTD authoring templates — more than 200 content templates are provided to simplify the process of automating and formatting guidance-compliant documents
- Document loading — uses a tool to import and export large collections of documents and/or file folders to leverage your existing data and files
- Single platform provides one-stop shop for R&D requirements
- Enables faster time to market through improved regulatory submission assembly, review and approval processes
- Allows you to quickly identify and assemble the relevant documents to support critical submissions
- Shortens review and approval cycles by up to 40%
- Allows for higher quality submissions with fewer iterations, enhancing chances for success
- Delivers automatic compliance with global eCTD standards
- Authoring templates allow authors to focus more on content and less on format.
- Enables you to adapt quickly to regulator or internal changes with flexible configuration capabilities
- Enhances productivity and efficiencies with prescribed best practices, hierarchy structures and sample workflows
- Reduces IT costs with flexible, out of the box system complete with validation test scripts to accelerate deployments
- Enhances maturity of submissions and document lifecycle processes to mitigate the risk of future compliance mandates, shifting business priorities and industry consolidation
- Pre-defined, fixed deliverable configurations appropriate to biotechs and other firms with rigid requirements are also available
QUMAS Compliance Solution Components