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Copenhagen-based Pharmaceuticals Manufacturer, Lundbeck, Selects CDC Solutions' EZsubs Software for Electronic Regulatory Publishing Submissions.


Business Editors/Hi-Tech Writers

PHILADELPHIA--(BUSINESS WIRE)--May 8, 2001

Ease of Integration With Documentum 4i Document Management System and

Compliance With New Regulatory Guidelines Play Significant Role in

Selection

CDC See Control Data, century date change and Back Orifice.

CDC - Control Data Corporation
 Solutions (CDC), a world-leader in multi-channel content delivery for regulatory and enterprise-scale publishing, today announced that H. Lundbeck A/S, an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological diseases, has selected CDC's EZsubs(TM) Publishing Suite to facilitate the transition from paper-based to electronic regulatory publishing submissions to the European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ), the U.S. Food & Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
), and other regulatory organizations worldwide.

Lundbeck chose EZsubs due to ease of integration with its existing Documentum 4i content management platform, and because of PDF- and XML-based functionalities that assist in meeting anticipated new compliance guidelines set by the FDA for 2002.

The company has initiated use of the EZsubs software for small-scale electronic submissions and expects complete implementation and full submissions by mid-year 2002. The Copenhagen, Denmark-based company lists 3,000 employees worldwide. It has recently opened its newest offices in Manhattan, New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
.

Founded in 1915, Lundbeck (www.lundbeck.com) is a unique pharmaceutical company focusing solely on the treatment of diseases of the central nervous system (CNS See Continuous net settlement.

CNS

See continuous net settlement (CNS).
).

CDC's EZsubs delivers an out-of-the-box solution that enhances a company's ability to meet the complex publishing requirements associated with regulatory submissions, and is designed to provide a flexible, configurable application for Lundbeck's submissions, which typically comprise approximately 100,000 pages and 350 volumes.

Lundbeck plans to couple EZsubs with FirstDocs(TM), a Documentum-based platform developed by First Consulting Group (www.fcg.com) to create an intuitive, scaleable, best-of-breed document management and publishing solution for its global business environment.

"The combination of EZsubs and FirstDocs will ease Lundbeck's transition to a paperless operation and allow them to realize the increased efficiencies provided by these technologies," said Chet Shemanski, Director of FirstDocs Solutions.

Claus Toftlund, Project Manager Electronic Submissions at Lundbeck said, "We research and develop treatments of diseases of the central nervous system - diseases such as depression, schizophrenia, Alzheimer's and Parkinson's. Submissions for these proposed treatments can exceed 100,000 pages, which need to be volumized, referenced by both sectional and cumulative tables of contents, properly paginated and, in some cases, watermarked and identified by headers and footers. CDC's EZsubs software will allow us to configure a standard solution to our specific needs, rather than developing an entirely new application, resulting in a seamless, efficient transition to electronic publishing An umbrella term for non-paper publishing, which includes publishing online or on media such as CDs and DVDs. ."

Features of the EZsubs solution include the ability to use existing source documents for publishing in a variety of formats, including print, PDF (Portable Document Format) The de facto standard for document publishing from Adobe. On the Web, there are countless brochures, data sheets, white papers and technical manuals in the PDF format.  and XML XML
 in full Extensible Markup Language.

Markup language developed to be a simplified and more structural version of SGML. It incorporates features of HTML (e.g., hypertext linking), but is designed to overcome some of HTML's limitations.
; functionality designed to facilitate both regulatory submissions and report publishing; ease of integration with Documentum and other content management platforms; and the capability to hyperlink cross-references between documents and volumes that span the entire submission.

Olaf Schoepke, Account Manager at CDC Solutions said, "Lundbeck is rightly recognized as a pioneer and specialist in the treatment of CNS disorders, and we are extremely pleased that they have selected EZsubs. EZsubs is a natural solution for the regulatory publishing needs of international pharmaceutical and life sciences companies such as Lundbeck. We are confident that EZsubs will contribute to Lundbeck's continued growth, and its ability to deliver world-class research and development efforts in the treatment of the various diseases of the central nervous system."

About CDC Solutions, Inc.

CDC Solutions is a World-leading provider of multi-channel content delivery publishing solutions that accelerate the assembly, dissemination and publishing of enterprise-scale publishing for paper, Intranets and the Web.

Since its foundation in 1994, CDC Solutions has guided companies on Corporate Publishing techniques and offered a range of solutions that comply with industry formats including XML, HTML HTML
 in full HyperText Markup Language

Markup language derived from SGML that is used to prepare hypertext documents. Relatively easy for nonprogrammers to master, HTML is the language used for documents on the World Wide Web.
, PDF, TIFF, GIFF See GIF.

GIFF - Do you mean GIF or is this some kind of IFF?
 and JPEG JPEG
 in full Joint Photographic Experts Group

Standard computer file format for storing graphic images in a compressed form for general use. JPEG images are compressed using a mathematical algorithm.
.

Working closely with global partners such as Documentum, Inc., Adobe Systems Adobe Systems Incorporated (pronounced a-DOE-bee IPA: /əˈdoʊbiː/) (NASDAQ: ADBE) (LSE: ABS) is an American computer software company headquartered in San Jose, California, USA. , Lotus and QUMAS, CDC Solutions has built an enviable reputation for high quality advanced technology coupled with an unrivaled team of experienced consultants and implementers to deliver corporate knowledge benefit.

CDC Solutions' electronic publishing products are in use by leading Pharmaceutical, Finance, Insurance, Utilities, Automotive and Media organizations both on a departmental and an enterprise level. Today, CDC Solutions is defining the way organizations publish corporate knowledge from simple personalized per·son·al·ize  
tr.v. per·son·al·ized, per·son·al·iz·ing, per·son·al·iz·es
1. To take (a general remark or characterization) in a personal manner.

2. To attribute human or personal qualities to; personify.
 documents to high scale regulatory submissions.

For more information, call +44 1291 635403 (United Kingdom) or 610/824-9021 CDC Solutions, Inc. (North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. ), or visit the CDC Solutions website at www.cdcsolutions.com.

CDC Solutions, CDC Solutions, Inc., EZsubs Publishing Suite, PDFfusion, PDFrender, PDFtools, PDFaqua, PDFcontrol, and Xtensia are trademarks or registered trademarks of CDC, Ltd. All other product and company names mentioned herein are trademarks of their respective holders.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:4EUSW
Date:May 8, 2001
Words:787
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