February 05, 2007 08:14 ET

QUMAS Launches R&D Compliance Suite Complete With Integration and Support Services

Only Suite Geared for R&D Operations to Tightly Integrate Content and Submission Lifecycle Management for Pharmaceutical and Biotech Companies

FLORHAM PARK, NJ -- (MARKET WIRE) -- February 5, 2007 -- QUMAS, a leading provider of quality management and regulatory affairs solutions, today announced the availability of the QUMAS R&D Suite™ for pharmaceutical and biotechnology companies. This is the first in a complete series of bundled solutions that QUMAS will deliver in 2007 for the life sciences and financial services markets. With the suite offerings, QUMAS will provide customers with complete service and support.

"In their efforts to automate manual compliance processes, our customers have struggled with integrating and managing all the solution components they need to achieve their business goals," said QUMAS Chief Executive Officer Kevin O'Leary. "Our integrated approach and one-stop service and support model, while not new in the enterprise software market, is a new and bold approach for the life sciences and financial services markets. With QUMAS suites, our customers can quickly roll out a complete and well tested compliance solution with built-in best practices."

The QUMAS R&D Suite -- an effective R&D strategy in a box -- assists life sciences companies in expediting the new drug application process with better quality submissions, fewer iterations and shortened review and approval cycles. At half the price of competing solutions, the QUMAS R&D Suite addresses a key market challenge -- integrating document and submissions management into one seamless lifecycle.

"Conventional submission management solutions are not enough," explained Ken Hayward, head of the QUMAS life sciences division. "By combining content authoring, content management, real-time collaboration and submission management, we provide one integrated solution for all functional R&D areas."

The QUMAS R&D Suite includes but, is not limited, to functions such as Regulatory Affairs, Clinical, Nonclinical, and Quality. Key components of the suite include:

--  A regulatory content management system
--  Submission Management System for assembly and compilation of compliant
    paper and electronic dossiers based on the CTD standard
--  Browser-based collaborative review and authoring solution in which
    everyone can simultaneously comment on the same copy of the document
--  eCTD authoring templates to simplify the process of automating and
    formatting guidance-compliant documents
--  Import/export tool used to import and export large collections of
    documents or file folders to leverage existing data and files
"The suite is all inclusive," observed Hayward. "It does not require additional sourcing, customization or integration to immediately deploy. Companies can immediately realize streamlined regulatory submissions."

"Companies are constantly searching for ways to bring prescription drugs to market more quickly and cost-effectively, without sacrificing safety and quality," said Chris Connor, senior research analyst at Health Industry Insights, an IDC Company. "A biotech or pharmaceutical company that can demonstrate this transparently, in full view of regulatory agencies, is making a significant statement -- one that makes both investors and acquisition suitors take notice."

"The QUMAS solution made perfect sense for us," said Jason Golan, project manager for Intercell, a biotech company on the verge of delivering its first product to market. "We needed a more systematic approach to compliance and required a solution that would provide us with a controlled, structured environment for creating and approving responses while accelerating time to market with critical submissions. QUMAS was able to address all of our needs while helping us meet stringent budget guidelines for the project."

In addition to bringing products to market sooner, companies utilizing the QUMAS R&D Suite realize the following benefits:

--  A single platform for fully integrated R&D requirements that deploys
    quickly and with a minimal IT footprint
--  Out-of-the-box compliance with 21 CFR Part 11
--  Ability to quickly identify and assemble the relevant documents to
    support critical submissions
--  Pre-defined and fixed configurations specifically made for biotechs
    and other firms that face rigid submission requirements
--  Review and approval cycles reduced by up to 40 percent
--  Automatic compliance with global eCTD standards
--  Authoring templates that allow authors to focus more on content and
    less on format
--  Enhanced maturity of submissions and document lifecycle processes to
    mitigate the risk of future compliance mandates
The QUMAS R&D Suite, available immediately, is the first in a series of life sciences suites that will focus on the areas of drug development and quality.


QUMAS is a leading developer of enterprise compliance management solutions designed to help life sciences organizations meet industry and government standards for 21 CFR Part 11, cGxP, Quality, Regulatory Affairs and Clinical Operations. With over a decade of experience, QUMAS is helping companies accelerate business processes, reduce costs and improve quality. From content lifecycle management, business process and change management to reporting and analysis, QUMAS Compliance Suite is successfully enabling global life science organizations to proactively manage their regulated content and processes in a secure and compliant way.

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