November 27, 2007 08:00 ET

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™ 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™. 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
--  Automated Notification & Distribution - enables effective distribution
    and rapid notification of document changes and approvals
--  Read & Understood - provides traceable accountability throughout the
--  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® 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® (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®, Kahalalide F; Zalypsis® 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.

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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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