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ESPS' New CDER 2.0 Software Allows Pharmaceutical, Biotechnology Firms To Submit Entire New Drug Applications Electronically Streamlines Submission Process from End-to-End
Fort Washington, PA -- July 29, 1999 -- ESPS, Inc. (Nasdaq: ESPS) today announced the introduction of the CoreDossier CDER 2.0 Compiler(tm) software solution which, for the first time, allows pharmaceutical and biotechnology companies to submit entire New Drug Applications (NDAs) electronically. The CDER 2.0 module addresses the latest U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) guidelines for regulatory submissions. Prior to the availability of CDER 2.0, the Food and Drug Administration (FDA) received portions of regulatory documents in varying combinations of paper and multiple electronic formats.
"The CDER Compiler 2.0 allows pharmaceutical and biotechnology firms to automate every aspect of their NDA electronic submission process," said Robert Kuller, global director of pharmaceutical and medical products markets at ESPS. "Getting a drug into the review process even a few days sooner can result in a significant first-mover competitive advantage."
The CDER Compiler 2.0 module is designed to operate with the powerful ESPS CoreDossier(r) 4.0 platform. This ESPS flagship product has set the standard for electronic regulatory- and business-compliance publishing. ESPS also has been first to market with Web-based product registrations and other Internet publishing solutions.
"It is estimated that nearly $100 billion is spent solely on the processes of filing compliance documentation," said Nathaniel Palmer, analyst at The Delphi Group. "These are not penalties for failing to comply, but rather obligatory costs.
"Hundreds of billions of dollars are diverted from research, product development, and investing opportunities, spent instead on paper pushing. So, ESPS works directly with major regulatory bodies -- like CDER -- to ensure that the knowledge embedded in each of its industry-specific modules is compliant with current requirements," Palmer said.
With the CoreDossier CDER 2.0 module, pharmaceutical and biotechnology companies have a standard that eliminates the need to create a custom application each time.
"The CDER guidance embraces PDF (Portable Document Format) as the de facto document interchange standard," said Susan Galle, global director of ESPS' regulatory and compliance group. "It takes full advantage of PDF forms technology and Acrobat Catalog indices which will be used for full text searching across an entire submission.
"The establishment of a common framework that allows sponsors to efficiently produce electronic submissions is a great leap forward. Additionally, since there is now a standard format and presentation of the supporting data and documents, reviewers at the agency and internally should be able to consume the information much more effectively," Galle said.
Some of the major features of CDER 2.0 Compiler(tm) include: Automatic generation of three-column tables of content; Automatic bookmarking of PDF files; Automatic translation of source documents; Quality assurance reporting specific to naming and directory information; Support of separate electronic/paper/raw data paths; and Support of multiple preparation options to allow maximum flexibility.
About ESPS ESPS, Inc. is the leading developer of electronic compliance (e-Compliance) management 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. The ESPS world headquarters is located in suburban Philadelphia, with additional offices throughout North America 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).
The statements in this news release which are not historical facts are forward-looking statements. These forward-looking statements involve risks and uncertainties that could render them materially different, including, but not limited to, the effect of fluctuations in our operating results, our reliance on a limited number of significant customers, our reliance on the CoreDossier product family, our ability to market and sell our products and services in our targeted industries, our ability to expand our sales and professional services organizations, our ability to manage growth, our ability to attract and retain qualified personnel, our reliance on relationships with service vendors, our reliance on licensed technology, our ability to protect our proprietary rights, potential year 2000 problems, our ability to compete in the rapidly evolving electronic compliance management market, the development and growth of the electronic compliance management market, our ability to respond to c Form S-1.
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CoreDossier is a registered trademark of ESPS, Inc. CDER Compiler 2.0 is a trademark of ESPS, Inc.
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