New Market Offering Unites QUMAS' Enterprise Compliance Management Systems and
Liquent's Content Assembly and Publishing Solutions
CORK, Ireland and FLORHAM PARK, N.J., June 25 /PRNewswire/ -- QUMAS, Ltd.,
global provider of Enterprise Compliance Management solutions for regulated
industries and Liquent, Inc. (Nasdaq: ESPS), the premier provider of content
assembly and publishing solutions today announced the global launch of
BioCompliance QL(R), a new biotechnology industry market offering designed to
manage the full compliance lifecycle and publishing requirements for
regulatory documentation.
Regulatory oversight within the biotechnology industry comes from several
agencies including the Food and Drug Administration (FDA), US Department of
Agriculture (USDA), and the Environmental Protection Agency (EPA) and the
European Medicines Evaluation Authority (EMEA). In the last 15 years, the
international regulatory standards for biologics have become considerably more
sophisticated and circumspect. This trend reflects improved production
methods, process controls, analytical methods, as well as the regulatory
reviewers' increased familiarity with rDNA product safety. The FDA
Modernization Act of 1997 (FDAMA) has forced greater harmonized review between
the Center for Drug Evaluation and Research (CDER) and Center for Biologics
Evaluation and Research (CBER) for biologic drugs. These trends place an
ever-increasing burden on biotechnology organizations to effectively manage
regulatory documentation throughout a more complex product development
lifecycle.
BioCompliance QL represents an innovative solution designed to address the
unique requirements of biotechnology companies, which must meet the records
and submission requirements of both CBER and CDER. The fully interoperable
offering leverages DocCompliance(R), QUMAS' Enterprise Compliance Management
technology and CoreDossierX(TM), Liquent's content assembly and publishing
solution.
BioCompliance QL offers full lifecycle electronic document control,
BLA/NDA submissions publishing, review and collaboration tools, 21 CFR Part 11
compliance, flexible acquisition options and professional services designed
for rapid deployment and validation. Using the BioCompliance QL solution,
biotechnology organizations will be able to reduce cycle times to prepare
submissions for regulatory agencies by effectively managing and publishing
regulatory documents. The solution includes built-in regulatory templates and
best practices for the preparation of a wide variety of regulatory documents.
QUMAS President, Kevin O'Leary commented, "BioCompliance QL represents a
landmark agreement for the benefit of biotechnology companies around the world
and a significant milestone for both QUMAS and Liquent. Both QUMAS and
Liquent strive to make regulatory compliance easier and this offering is a
significant step in the right direction."
Liquent President & CEO Rick Dool added, "The biotechnology industry is
aggressively pursuing new and innovative products to improve the health and
save the lives of many throughout the world. We are pleased to be combining
our market leading solutions with those of QUMAS to provide quality solutions
to help biotechnology organizations of all sizes achieve their ultimate
goals."
About Liquent
Liquent (formerly ESPS) is the leading provider of content assembly and
publishing solutions for the Life Sciences industry. Built on proven, world-
class rendering technology that transforms proprietary content into open
formats such as XML and PDF, Liquent software and services are used by 15 of
the top 20 global pharmaceutical companies. As a result, our solutions --
including our flagship software, CoreDossierX- have become the industry
standard for the production of new drug applications (NDAs), reports, bids and
proposals, and technical documentation. Liquent's content middleware
technology enables information assets to be assembled, published, and
repurposed for maximum value. Offering seamless integration with leading
document management systems and file systems, our solutions retrieve
information from virtually any source format and repository and automatically
convert it into high-fidelity renditions that can be easily combined or
distilled to meet any need. In addition to its headquarters in suburban
Philadelphia, Liquent maintains offices in the United Kingdom, La Jolla, CA,
Latham, NY, and Research Triangle Park, NC. http://www.liquent.com.
About QUMAS
QUMAS, Ltd., is the leading developer of Enterprise Compliance Management
Solutions designed to help regulated industries ensure regulatory compliance.
For over a decade, QUMAS has been providing industry-proven Enterprise
Compliance Management solutions to market leaders in the pharmaceutical,
medical device, biotechnology and contract research industry sectors. Using
advanced technology and regulatory domain intelligence, QUMAS' pre-packaged
compliance management solutions automate critical document processes and
dramatically reduce document cycle times. QUMAS solutions deploy rapidly to
deliver FDA (including 21 CFR Part 11 electronic signature and records), EMEA
and ISO-related best practices for the automation of controlled documentation
and electronic regulatory submissions. QUMAS services include validation,
user training, migration services and technical support as part of a total
software and services offering. QUMAS, Ltd. is based in Cork, Ireland, with
US headquarters in Florham Park, NJ, with additional offices throughout the
United States. For more information, please visit our Web site http://www.QUMAS.com
or contact QUMAS at +353 21 4320050 (Europe) or (973) 377-8750 (North
America).
SOURCE QUMAS, Ltd.
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Related links:
http://www.QUMAS.com
CONTACT:
USA: Grace Cohen of Demaree Public
Relations, 603-428-4411, gcohen@demaree-pr.com, or Valarie
King-Bailey of QUMAS, 866-546-5586, vkingbailey@qumas.com;
IRELAND: Paul O'Dwyer of QUMAS, + 353 21 4320050,
podwyer@qumas.com
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