January 22, 2007 08:00 ET

QUMAS and EXTEDO/IABG-LSS Deliver Integrated Document and Submission Management Solution to Intercell

FLORHAM PARK, NJ -- (MARKET WIRE) -- January 22, 2007 --QUMAS, a leading provider of quality management and regulatory affairs solutions, today announced that biotechnology company Intercell AG has implemented the QUMAS Compliance Suite™ and the eCTDmanager Suite™ from EXTEDO/IABG Life Sciences Solutions (IABG-LSS). The combined solution provides Intercell with an integrated electronic document and submission management system to support the critical submissions phase for drug licenses.

Intercell, founded eight years ago, and now on the verge of commercializing their first vaccine, selected QUMAS and EXTEDO/IABG-LSS to establish an automated, auditable, controlled environment for compiling and managing controlled documents for their submission to the FDA and appropriate regulatory bodies.

"The QUMAS/IABG-LSS solution provides us with a controlled, structured environment that accelerated our time to prepare for the submission, while eliminating previous paper-based processes and establishing best-practice rules to reduce potential issues with the submission," said Jason Golan, project manager for Intercell.

"At every step of the submissions process, we now have an auditable trail that identifies where we are in that process and we know who is responsible at this phase in the process."

"Many young, innovative biotech companies reach a point in their development which triggers the need to have tighter controls in the way that they manage their compliance requirements systems," said Ken Hayward, head of the QUMAS life sciences division. "They want a system that is simple to install, easy to use and comprehensive enough to meet the rigorous regulatory requirements of the FDA and other regulatory authorities around the globe. The QUMAS/EXTEDO/IABG-LSS solution meets all of these needs."

"Our partnership with QUMAS allowed us to meet Intercell's strict time and quality constraints," said Andreas Suchanek, Managing Director of IABG-LSS. "As the European Union and the FDA steer companies towards electronic submissions, we expect more companies will require a strong electronic dossier management system and a closed loop compliance component to be delivered within a short period of time."

About QUMAS Compliance Suite

The QUMAS Compliance Suite enables life science companies to effectively manage the creation, review, approval and revision of the content; efficiently interact with submission management systems; and, ease the process for handling Process Change Control, Adverse Events and other data-centric requirements. The QUMAS web-based application suite enables organizations to consolidate and manage their regulatory compliance requirements through a configurable enterprise software suite. Accessed through the CompliancePortal™, which provides a role-based point of access, the Compliance Suite includes two complete software applications -- DocCompliance™ and ProcessCompliance™.


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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About eCTDmanager Suite

EXTEDO's eCTDmanager Compliance Suite is a comprehensive and easy-to-use Regulatory Submission Management system for the straightforward assembly and compilation of compliant electronic dossiers based on the ICH eCTD and 21 CFR Part 11 standards. eCTDmanager supports both electronic and paper publishing for submissions to all regions across the world. DOCvalidator provides automated document compliance checks on PDF and Word documents.


EXTEDO/IABG-LSS is a global leader in electronic regulatory submission and document compliance solutions focused on the life cycle management and approval of pharmaceutical and crop protection products and medical devices. With over a decade of experience, EXTEDO/IABG-LSS is helping companies advance the process of bringing Life Sciences solutions into the marketplace. EXTEDO/IABG-LSS' focus is on pharma, crop protection, biotechnology, biocides and medicinal products. Solutions from EXTEDO/IABG-LSS support all current standards of paper based, hybrid and electronic submissions such as CTD, eCTD, CADDY and more. EXTEDO/IABG-LSS' software products include eCTDmanager™, DOCvalidator™, PlantOS™ and EURS is Yours™, an electronic review system for eCTDs at the EMEA (European Medicines Agency), European Authorities and worldwide pharmaceutical companies.

EXTEDO is the North American division of IABG Life Sciences Solutions. EXTEDO/IABG-LSS is privately owned and has offices in Germany and the United States. For more information on EXTEDO/IABG-LSS and its solutions visit and

About Intercell AG

Intercell AG is a biotechnology company focused on the research, development, manufacturing and future commercialization of innovative vaccines for the prevention and treatment of infectious diseases, for which there exists a substantial unaddressed medical need. Intercell develops antigens and immunizers (adjuvants), which are derived from its proprietary technology platforms and has in-house GMP manufacturing capability. Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Wyeth, Sanofi Pasteur S.A., Merck & Co., Inc., Kirin Brewery Co., Ltd. and the Statens Serum Institut. Intercell has a broad development pipeline with a vaccine product candidate for Japanese Encephalitis in Phase III clinical trials, a vaccine product candidate for Hepatitis C in Phase II, partnered vaccine candidates for Tuberculosis and S.aureus, which are in Phase I, and more than five other product candidates focused on infectious diseases in pre-clinical development. Intercell is listed on the Vienna stock exchange under the symbol "ICLL."

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