QUMAS R&D Solution provides Life Science Organizations with a Closed-Loop Compliance Environment: Enables faster time-to market for new drugs

JERSEY CITY, NJ – June 27, 2011 - With ever-increasing regulation, global competition and market expectations, Cork, Ireland-based QUMAS delivers proven regulatory compliance solutions to pharmaceutical, and biotechnology companies. Delivering R&D compliance solutions, QUMAS provides an efficient one-stop shop for submissions lifecycle management. At the 2011 Bio-International Convention, QUMAS is showcasing its services at The Walter E. Washington Convention Center, Washington DC, Booth 2441 (June 27 – 30, 2011), as part of the Enterprise Ireland Delegation.

Being proactive in regulating and resolving violations across an enterprise in a consolidated and consistent way is a common challenge across the life science industry. QUMAS delivers a closed loop compliance model that standardizes and integrates the common elements of compliance tasks across the organization. This model allows enterprises to effectively converge all of their compliance programs onto a single platform.

The QUMAS R&D Solution is the answer to many companies’ challenges for creating and approving submission, which can delay marketing new drugs and affect business performance. QUMAS offers one integrated solution for all functional R&D areas, combining content authoring, content management, real-time collaboration and submission management.

“We believe in taking advantage of a complete R&D strategy,” said Kevin O’Leary, CEO, QUMAS. “Our solution enhances productivity and efficiencies, and reduces IT costs. Most importantly, it enhances the maturity of submissions and document lifecycle processes to mitigate the risk of future compliance mandates, shifting business priorities and industry consolidation.”

The 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

“Technology from QUMAS gives organizations a complete and timely compliance management solution to help them manage change,” continued O’Leary. “The demand for our solution continues to grow steadily and new product innovations, such as the launch of MyQUMAS and our SharePoint 2010 based solution, will bring us into new markets.”

Enterprise Ireland is the government agency responsible for the development and promotion of the indigenous business sector. Enterprise Ireland’s mission is to accelerate the development of world-class Irish companies to achieve strong positions in global markets resulting in increased national and regional prosperity.

The other companies attending the 2011 Bio-International Convention as part of the Enterprise Ireland delegation include Merrion Pharmaceuticals (http://merrionpharma.com), Solvotrin Therapeutics (http://www.solvotrin.com), QUMAS (http://www.qumas.com), FRKelly (http://www.frkelly.com), BCO Pharma Ltd. (http://bcopharma.com), Innopharma Labs (http://www.innopharmalabs.com), CodeX Discovery (http://www.codexdiscovery.com), Fountain Healthcare Partners (http://www.fh-partners.com/) and Zenith Technologies (http://www.zenithtechnologies.com/display.php).