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Compliance Offering Extended to Meet the eCTD FDA 2008 Guidance

Eschborn, Germany – February 5th – 8th, 2008 - Image Solutions Inc. (ISI), a leader in providing software and services to streamline the drug development and regulatory approval process, today announced the company has extended its relationship with EMC Corporation, enabling the company to co-sell its integrated regulatory suite with EMC’s Enterprise Content Management solutions. The Compliance-in-a-Box (CiB) Submission Edition is a pre-packaged, integrated regulatory compliance solution that gives organisations the flexibility they need to submit in paper or electronically using the electronic Common Technical Document (eCTD) format.

The eCTD is now the globally accepted format established by the International Conference on Harmonisation (ICH). The combination of a document management solution packaged with a publishing system allows companies to achieve enhanced content creation and management, eCTD generation, and true document lifecycle management.
Previously, mid-market pharmaceutical and biotechnology companies have found compliance solutions to be costly and complex. The CiB solution can be implemented in a fraction of the time of traditional content management/publishing systems as a result of a rapid configuration and deployment approach offered by Impact Systems.

EMC and Impact launched the first phase of CiB late last year. Based on several successful implementations, EMC and Impact have delivered the package in just weeks. The new CiB Submission Edition extends the value of CiB and enables Life Sciences companies to meet the January, 2008 FDA Regulatory Submissions eCTD guidance at a cost-effective price and within accelerated implementation timeframes.

The backbone of the solution is EMC Documentum Compliance Manager (DCM), combined with Impact’s accelerator configuration package, which together delivers a set of pre-configured templates and document types based on industry best practices.
Page 2/Compliance-in-a-Box Submission Edition
DCM is tightly integrated with ISI’s regulatory suite, which includes:

 eCTDXPress - for submitting content electronically to regulatory agencies.
 ISIPublisher. for supporting paper-based and non-eCTD electronic submissions (commonly known as hybrid or NeeS submissions).
 Virtual Link Manager - maintains cross-document hyperlinks even when both the source and target documents have changed.

“This is an industry first where the two best-in-class compliance providers collaborate to configure a packaged solution to deliver sophisticated regulatory compliance to mid-market companies,” commented Paul Chung, executive vice president of ISI. “The decision to target the mid-market is fueled by our belief that they have the same sophisticated needs as their market-leading counterparts, and that a packaged solution delivered using a compelling licensing and deployment model can provide a win-win for the pharmaceutical companies and vendors alike.”

In commenting about the extended relationship with ISI, Mark Arbour, General Manager of Rich Media and Compliance, EMC Documentum said, “This is a powerful proposition for mid-market pharmaceutical companies. We are delighted for the opportunity to work with ISI to develop and bring to market a world-class packaged regulatory compliance solution that combines the best of both technologies.”

Tags: eCTD publishing integration with DMS; regulatory submission publishing; ICH electronic common technical document; EDMS document management; eCTD; electronic submissions; document lifecycle management
Suggested Links: FDA eCTD Guidance; ICH Specification

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 Science organizations as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firm to deliver electronic submissions to the industry and has since delivered nearly 1,000 electronic submissions. ISI serves the top 50 Pharmaceutical and Biotech organisations, in addition to the leading companies in other regulated industries.

ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the US, Europe and Asia. For more information, visit the company website at

PR Contact
Carina Birt
+44 1722 411150

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