QUMAS - QUMAS to Provide PharmaMar : NON-REG

Tue Nov 27, 2007 8:00am EST

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RNS Number:5114I
QUMAS
27 November 2007


QUMAS to Provide PharmaMar With Comprehensive Regulatory Content Management
Solution


Global Biopharmaceutical Leader Looks to QUMAS DocCompliance to Ensure
Consistent Enterprise-Wide Compliance


JERSEY CITY, NJ--(Marketwire - November 27, 2007) - QUMAS, a leading provider of
quality management and regulatory affairs solutions, today announced that
PharmaMar, a biopharmaceutical company subsidiary of Spain-based Zeltia Group,
has selected QUMAS DocCompliance(TM) as its regulatory content management
system. With QUMAS DocCompliance, PharmaMar now has a single solution that
enables it to electronically create, manage and securely store all content,
reports and records related to bringing pharmaceutical drugs to market, a
critical precursor for eCTD submission.


For PharmaMar, the QUMAS solution will help the company meet new eCTD standards.
The FDA announced that starting January 1, 2008, eCTD will be the only accepted
electronic submission format. At PharmaMar, QUMAS DocCompliance will be
integrated with EXTEDO/IABG-LSS StudyManager(TM). StudyManager provides an easy
and accurate way to create studies separately from, and prior to, the
preparation of an eCTD that includes the study. At any time during the creation
of the eCTD the entire study is added to the eCTD with one simple "drag and
drop" operation from StudyManager.


Deployed at major pharmaceutical and biomedical companies across the globe,
QUMAS DocCompliance provides:

-- Role-Based Electronic Signatures - ensures that the meaning of
   electronic signatures match user intent
-- Workflow & Configuration Management - allows users to map their unique
   business processes to the system without customization
-- Advanced Lifecycle Management - convenient access to all document
   lifecycles
-- Automated Notification & Distribution - enables effective distribution
   and rapid notification of document changes and approvals
-- Read & Understood - provides traceable accountability throughout the
   organization
-- Comprehensive, Independent Audit Trail - QUMAS DocCompliance captures
   more than 270 auditable events, allowing export or printing for regulatory
   agency review

"Given the ever changing regulatory landscape, organizations find it extremely
challenging to quickly identify, assemble, review and approve all the relevant
documents," said Ken Hayward, executive vice president for QUMAS. "With QUMAS
DocCompliance, PharmaMar can deploy a solution that helps them operate in a
continuous state of compliance at all times, even as new regulations come to the
forefront."


About PharmaMar


PharmaMar is the world's leading biopharmaceutical company in advancing cancer
care through the discovery and development of innovative drugs from marine
origin. The company, based in Madrid (Spain) is a subsidiary of Grupo Zeltia
(Spanish stock exchange, ZEL).


PharmaMar commercializes Yondelis(R) for the treatment of advanced soft tissue
sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to
receive these agents. The agent received last September the Authorization for
Commercialization in this indication becoming the first Spanish anti cancer drug
to be approved in Europe and the first from marine origin in the world.


The strong R&D programme of PharmaMar has resulted in a rich pipeline: Yondelis
(R) (co-developed with Johnson & Johnson Pharmaceutical Research & Development,
L.L.C.) is in phase III for ovarian cancer and phase II for prostate, breast and
paediatric cancers; Aplidin(R), Kahalalide F; Zalypsis(R) and PM02734 that are
in clinical trials in diverse malignant tumours. More than 6,000 cancer patients
have already been treated with PharmaMar agents in clinical trials in more than
100 hospitals in Europe, the US and Canada.


Founded in 1986, with the vision of exploiting the great potential of the oceans
as a source of novel medicines for improved cancer treatment, PharmaMar has a
unique collection of 50,000 marine organisms obtained from expeditions around
the world. A total of 700 new chemical entities have been discovered and 100 new
families of compounds have been identified. PharmaMar also has three molecules
in advanced preclinical development.


For more information visit http://www.pharmamar.com


About QUMAS


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.


For more information visit http://www.qumas.com. 

MEDIA CONTACTS:
Michael Kane
QUMAS
(978) 257-2179
mkane@us.qumas.com
http://www.qumas.com

Michael Aalto
Davies Murphy Group, Inc.
781-418-2416
qumas@daviesmurphy.com
http://www.daviesmurphy.com




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