ISIToolBox 6.0 Speeds Electronic Submissions for Faster Time-To-Market: -- Newest Version of Industry's Leading Adobe Acrobat Plug-In Toolset Speeds Assembly and Management of eCTD-Compliant Submissions

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Image Solutions, Inc. (ISI), a leading provider of software and services to streamline the drug development and regulatory approval process, today announced the release of ISIToolBox(R) version 6.0, the latest version of ISI's flagship toolset for creating and managing volumes of regulated documents maintained by pharmaceutical organizations. ISIToolBox, which is currently used by 45 of the top 50 global pharmaceutical companies, allows users to create, edit and manage regulatory-compliant documents.

    With ISIToolBox 6.0, the company has now incorporated a powerful set of sophisticated tools found in Compose(R), a document publishing solution owned by more than 6,000 global customers. Compose is being sunset and customers will be migrated to ISIToolBox Standard Edition. The combination of ISI's new development work for ISIToolBox 6.0, and an innovative toolset from Compose, together represents a unique productivity-enhancing solution for organizations striving to improve worker efficiencies and automate manual tasks during the publishing process.

ISIToolBox 6.0 provides a set of 50 Adobe Acrobat PDF plug-ins designed to allow companies to work with PDFs more efficiently while eliminating the challenges, cost and work involved in preparing electronic documents for report-level publishing. The product represents more than 10 years of development work by ISI to systematically eliminate manual tasks during the process. Today, ISIToolBox 6.0 offers the pharmaceutical industry the broadest Adobe Acrobat plug-in tool set, allowing users to bookmark documents instantly or create thousands of hyperlinks in a single step.

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ISIToolBox 6.0 also automates the creation of a Table of Contents based on bookmark information or current document structure of a PDF. It can also search documents and replace key words or phrases with different text or redaction. Other key functions include: link and bookmark validation; text and graphic extraction; and automated formatting based on customized preferences.

Starting this past January 1, 2008, the U.S. Food and Drug Administration (FDA) now only accepts electronic submissions in the electronic Common Technical Document (eCTD) format. Pharmaceutical companies large and small are addressing this requirement by rethinking and reconfiguring their regulatory documentation and submission processes. ISIToolBox 6.0 offers an intuitive interface that helps with institutional adoption and improves productivity through more efficient document management practices. ISIToolBox 6.0 has been shown to achieve efficiency gains of nearly 70% in file preparation time and 75% reduction in the time needed to conduct quality assurance of a submission.

Tags: PDF Conversion; PDF conversion for document management; FDA compliance; eCTD; regulatory submission publishing; electronic submissions

Suggested Links: ISI Web site; Adobe Web site; FDA eCTD Guidance

About Image Solutions, Inc.

Founded in 1992, Image Solutions, Inc. (ISI) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered nearly 1,500 electronic submissions and 650 eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organizations as well as the top companies in other regulated industries.

ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognized charitable organizations. For more information, visit the company website at http://www.imagesolutions.com.

Image Solutions, Inc., ISIToolBox, eCTDXPress, ISIPublisher and ISIRegTracker are trademarks or registered trademarks of Image Solutions, Inc. which may be registered in the United States and internationally. Other brand names may be trademarks or registered trademarks of others.

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Matt Hantz
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