September 10, 2007 08:00 ET

QUMAS R&D Solution Selected by Cytochroma to Automate Its Submission Initiatives

QUMAS Chosen for Its Ability to Comply With FDA Electronic Submission Mandate

FLORHAM PARK, NJ--(Marketwire - September 10, 2007) - QUMAS, a leading provider of quality management and regulatory affairs solutions, today announced that Cytochroma has selected the QUMAS R&D Solution as its complete compliance solution for content and submissions management. Cytochroma is one of three Canadian life sciences customers that have purchased the QUMAS R&D Solution in the last 90 days.

Cytochroma Inc. is a development stage specialty pharmaceutical company focused on the treatment and prevention of disorders related to Vitamin D insufficiency. The company has a portfolio of therapeutics with lower development risk for the indications of Vitamin D insufficiency and for secondary hyperparathyroidism associated with chronic kidney disease. Cytochroma's pipeline products address significant unmet medical needs with a target market that is expected to grow significantly, reaching more than $1.2 billion annually by 2010 in North America alone.

The QUMAS R&D Solution -- 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. The QUMAS R&D Solution allows Cytochroma to integrate document and submissions management into one seamless lifecycle.

After a thorough multi-vendor review process that included outside agencies as well as Cytochroma's exhaustive internal selection process, Cytochroma selected the QUMAS R&D Solution since the company felt it offered the most comprehensive and customizable platform available on the market.

"Regulatory submissions are vital to our business," said Susan Peers, Ph.D., Director, Regulatory Affairs and Quality Assurance of Cytochroma. "This system allows us to prepare and publish FDA-compliant electronic regulatory submissions in-house. With the QUMAS R&D Solution, we can be sure that our business owners throughout the company are following a consistent method of creating, managing and securely storing all content, reports and records greatly increasing the efficiency of our submission preparations."

"The approaching FDA deadline mandating electronic submissions has made a number of companies reexamine their compliance practices," said Ken Hayward, executive vice president of QUMAS. "The QUMAS R&D Solution provides out-of-the-box functionality required for companies to meet the FDA new submissions standards while being customizable enough to adapt to any enterprise workflow."

About Cytochroma Inc.

Cytochroma Inc. ( is a specialty pharmaceutical company engaged in the development and commercialization of proprietary products to treat and prevent the clinical consequences of Vitamin D insufficiency. The Company has an advanced portfolio of new therapies for Vitamin D insufficiency and secondary hyperparathyroidism associated with chronic kidney disease. In addition, the Company is developing novel therapies to treat hyperproliferative disorders, such as cancer and psoriasis, and hyperphosphatemia.


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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