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ESPS Introduces CoreDossier 4.0; Links Corporate Compliance Groups Directly to Regulatory Agencies.


FORT WASHINGTON Fort Washington, military post during the American Revolution, situated on the highest point of Manhattan island, New York City, overlooking the Hudson River opposite Fort Lee, N.J. , Pa.--(BUSINESS WIRE)--May 20, 1999--

Leading pharmaceutical, chemical, utility companies leverage

e-Compliance capability; can realize 30 percent or more reduction in

time, costs associated with regulatory submissions

ESPS ESPS Essential Small Pharmacies Scheme (UK)
ESPS East Spring Primary School (Singapore)
ESPS Electrode-Separated Piezoelectric Sensor
, Inc. (Electronic Submission Publishing Systems, Inc.), a leading developer of electronic compliance (e-Compliance) solutions, today announced the expanded functionality and new version of the company's flagship software product family, CoreDossier(R) 4.0. CoreDossier has already become a vital link between corporate compliance groups and regulatory agencies regulatory agency

Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S.
 by enabling companies to electronically assemble and submit regulatory submissions and other compliance information. The new version contains features developed in response to the changing regulatory environment, as well as user input.

A number of regulatory agencies are developing electronic submission standards. The U.S. Environmental Protection Agency Environmental Protection Agency (EPA), independent agency of the U.S. government, with headquarters in Washington, D.C. It was established in 1970 to reduce and control air and water pollution, noise pollution, and radiation and to ensure the safe handling and  (EPA EPA eicosapentaenoic acid.

EPA
abbr.
eicosapentaenoic acid


EPA,
n.pr See acid, eicosapentaenoic.

EPA,
n.
) estimates that the total cost of compliance reporting to the EPA is $5 billion per year and growing. This number includes the cost of data collection, document production and distribution, as well as that of review, including personnel costs. In an attempt to streamline processes and cut compliance costs, the EPA is developing electronic reporting standards and plans to only accept electronic filings by 2003.

"We are very excited about the availability of CoreDossier 4.0, as it will enhance our customers' ability to quickly and efficiently submit compliance documents," stated Terrance Brennan, chief executive officer and president of ESPS. "Many of the new features available in this version of the product were developed in response to requests from corporate regulatory managers, as well as feedback received from regulatory agencies. ESPS' unique position as a conduit between these two parties has made CoreDossier a must-have for companies in highly-regulated industries."

ESPS customers, including Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History
Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees.
 Transnational, Bayer Agrochemical agrochemical

Any chemical used in agriculture, including chemical fertilizers, herbicides, and insecticides. Most are mixtures of two or more chemicals; active ingredients provide the desired effects, and inert ingredients stabilize or preserve the active ingredients or aid
 and Baltimore Gas and Electric, have utilized CoreDossier to substantially reduce the time and costs associated with the assembly, management and submission of regulatory documents. These savings often translate into millions of additional revenue dollars. Additionally, CoreDossier has helped other leading companies in highly regulated industries, including pharmaceuticals, utilities and chemicals, prepare for the electronic reporting standards set by regulatory agencies.

The CoreDossier 4.0 electronic compliance management software suite enables organizations to efficiently assemble, collaborate, distribute, review, publish and reuse regulatory and other business compliance information.

This new version includes support for 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.
; support for users creating publications based on paragraphs of information, in addition to full documents; publishing capabilities for forms-based documents; and enhanced functionality for tables of content and cross-references. Further, CoreDossier 4.0 provides a universal data-publishing gateway for seamless integration An addition of a new application, routine or device that works smoothly with the existing system. It implies that the new feature or program can be installed and used without problems. Contrast with "transparent," which implies that there is no discernible change after installation.  of data and documents, working with most document management systems.

"ESPS has identified issues surrounding regulatory reporting and has used technology to define and develop the e-Compliance market," said Nathaniel Palmer Nathaniel Brown Palmer (1799 – 1877) was a seal hunter, explorer, sailing captain, and ship designer. He was born in Stonington, Connecticut. During the 1810s the skins of Antarctic Ocean seals were highly valued as items for trade with China. , analyst with The Delphi Group. "CoreDossier has already made an impact on how companies in highly regulated industries handle their regulatory submission process."

Leading companies in the pharmaceutical industry have been using CoreDossier to streamline the process of submitting new drug applications to 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.
). In addition to decreasing the time to assemble a submission from days to hours and even minutes, the associated costs of this compliance burden can be reduced by 30 percent or more. CoreDossier streamlines the compliance process, hence helping companies bring drugs to market faster - resulting in potentially millions of dollars in additional revenue.

"Zeneca is planning to use ESPS' CoreDossier 4.0 for electronic and paper submissions in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , throughout Europe and, eventually, Japan," said Greg Rullo, Zeneca's Emergent Dossier Project Manager. "We're looking to CoreDossier 4.0 to provide the value-added advantage to take Zeneca to the next level."

About ESPS

ESPS, Inc. (Electronic Submission Publishing Systems, Inc.) is a leading developer of electronic compliance (e-Compliance) solutions used to manage, publish and share regulatory submissions and other business compliance information. ESPS solutions address the needs of companies faced with regulatory compliance submission requirements through the application of industry expertise, advanced technology and a commitment to high-quality implementations. The ESPS CoreDossier (R) software solution has set the standard for electronic compliance management in industries, including pharmaceutical, chemical and utilities, among others. The ESPS world headquarters is located in suburban Philadelphia, with additional offices throughout 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.  and in Europe. More information can be found at www.esps.com, or by reaching the company at 800.515.ESPS (North America) or +44 (0) 1753 725203 (Europe).

CoreDossier is a registered trademark of ESPS, Inc.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 20, 1999
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