JERSEY CITY, NJ — October 14, 2008 - QUMAS, a leading provider of regulatory compliance solutions, today announced that Avigen, a biopharmaceutical company developing innovative therapeutics for the treatment of chronic neurological conditions, has selected QUMAS as its document management partner of choice. In phase one of the project, Avigen will implement QUMAS DocCompliance™ as its regulatory content management system for quality assurance and document control. In phase two of the project, Avigen will extend the implementation to meet its regulatory affairs requirements.
"Avigen selected QUMAS because of its proven ability to address the full range of regulatory compliance requirements," said Andrew Sauter, CFO at Avigen. "As we prepare for the more rigorous regulatory demands of later-stage clinical development, we believe QUMAS has the solutions and experience necessary to ensure our return on investment, and eliminate the need to manage disparate and isolated compliance systems."
Deployed at major pharmaceutical and biomedical companies across the globe, QUMAS Compliance Solutions enable organizations to quickly respond to new regulations and legislative demands, avoid costly content and process duplication, enforce and automate best practices while ensuring consistency across the company.
QUMAS is the leader in Enterprise Regulatory Compliance Solutions with more than 250 customer deployments. QUMAS solutions are designed to achieve compliance with industry and government standards for 21 CFR Part 11, cGxP, Quality, R&D, Regulatory Affairs and Clinical Operations. QUMAS enables organizations to bring new drugs to market faster while proactively managing regulated content and controls, reducing costs, and improving customer satisfaction.
For more information visit www.qumas.com
Avigen is a biopharmaceutical company focused on developing and commercializing small molecule therapeutics to treat serious neurological disorders, including neuropathic pain and neuromuscular spasm and spasticity. Avigen's strategy is to complete the requirements of clinical development for each of the candidates in its product pipeline, and continue to look for opportunities to expand its pipeline through a combination of internal research, acquisitions, and in-licensing, with the goal of becoming a fully integrated commercial biopharmaceutical company that remains committed to its neurology products. Avigen is currently developing AV650 for spasticity and neuromuscular spasm and AV411 for neuropathic pain, as well as opioid withdrawal and addiction in collaboration with the National Institute of Drug Abuse. Additionally, the company is advancing AV513, a novel therapy for the treatment of multiple bleeding disorders, including hemophilia A and B, toward clinical trials.
For more information visit www.avigen.com
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