R&D Solution from QUMAS

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.

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 — Import/export tool used to import and export large collections of documents and/or file folders to leverage your existing data and files

Benefits:

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

Download the QUMAS Biotechnology Package Brochure.