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Integrated Regulatory Solutions Suite reduces process redundancies, shaves time off submission cycles, and facilitates submissions in other regions and application formats

Eschborn, Germany – June 10th, 2008 – Image Solutions, Inc. (ISI), a leading provider of software and services for the life sciences industry today announced a new suite of integrated regulatory solutions that enable pharmaceutical organisations to maximise opportunities across multiple markets and to shave weeks off submission cycles with a single, highly configurable software suite for assembling, reviewing, and compiling/publishing submissions. The Regulatory Solutions Suite is further affirmation of ISI’s commitment to easing the burden and repetition associated with the submissions process.

The comprehensive new solution combines ISI’s flagship products, eCTDXPress and ISIPublisher, with several new powerful features that remove a substantial administrative burden from the Regulatory Affairs or Operations departments in their efforts to accelerate timelines for taking products to market. At the same time, the new solution eliminates rework that could prevent or stall companies from exploring new market opportunities.

Commenting on the introduction of the new integrated Regulatory Solutions Suite, Gilbert Kampfner, Managing Director of ISI Europe said, “With this suite, it has never been easier for life sciences organisations of all sizes to navigate the complexities of regulatory submissions, whatever format they take, thereby opening up new markets. We are pleased to be able to offer this comprehensive suite of solutions, which firms can buy either as a single end-to-end product set, or by choosing and mixing separate modules to suit their individual needs.”

The integrated ISI Regulatory Solutions Suite allows pharmaceutical organisations, whatever their size, to fully leverage their existing product portfolios because of the ease by which they can now make submissions to all associated countries. This enables them to maximise the technology return on investments already made when conducting drug development. In addition, the Suite allows creation of any application format from within the same product suite based on an existing application regardless of starting point – electronic Common Technical Document (eCTD), paper dossier, or non-eCTD Electronic SubmissionS (NeES), dramatically reducing the amount of rework.

For companies already leveraging one of ISI’s submission products, the path forward is simplified, as all ISI products share a robust submission management tool, common user interface, back-end database, and some common functionality that allow the products to work seamlessly together. With this foundation in place, companies will also be able to add applications in a stepwise fashion as business demands grow or the submission environment becomes more complex.
This is critical given the number and variety of countries and agencies in the EU, making the submissions process across Europe extremely onerous. Differing standards, requirements, and inevitable language hurdles make it difficult to successfully submit products to as many countries as might be desired. While the eCTD is gaining acceptance as the standard across Europe, differing legal and regulatory requirements make it difficult to develop a single strategy that accommodates all countries. Despite these challenges, the European community remains one of the industry’s biggest opportunities, especially as the divisions with Eastern Europe fall away and large countries such as Russia rise in prominence and spending power.

The Regulatory Solutions Suite bridges the gap between the submission assembly in all different formats currently accepted in the EU, and the management and relation of these different submission formats, providing an essential first step toward submission and information management. Of critical importance is the Regulatory Solutions Submission Manager, a new module in the Suite, which provides a single view of all submissions, focusing on document management, metadata, and the relationships between submissions. This provides the point of integration between ISI’s platform for assembling and managing eCTDs, eCTDXPress, and ISIPublisher, ISI’s platform for assembling and publishing paper-based or NeES submissions.

The ISI Regulatory Solutions Suite can be purchased as an end-to-end suite, or as standalone modular applications. A key component of the ISI Regulatory Solutions Suite, ISIRegTracker, offers a comprehensive submission tracking and licensing management solution, completing the information management requirements of any Regulatory Operations/Affairs department. Further productivity gains are provided by the Virtual Link Manager (VLM) and ISIRender tools which have been built on the same platform, and are easily integrated into the solution. These perfectly complement the regulatory submission process, enabling the business to decide when to perform critical process steps, whether upstream or downstream.

To find out more about the ISI Regulatory Solutions Suite please visit the company website on www.imagesolutions.com.

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About Image Solutions

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 firm to deliver electronic submissions to the industry and since has delivered more than 1,500 electronic submissions and 800+ eCTD submissions. The company has a 48 percent market share among Top 50 global pharmaceutical for its flagship submission product, eCTDXPress, and 4 of the top 10 pharma now have ISIPublisher.
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 recognised charitable organisations. For more information, visit the company website at www.imagesolutions.com.

PR Contact:

Carina Birt
PR for ISI Europe
Email: carina@sarumconsultancy.co.uk
Tel: +44 1722 411150

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