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Image Solutions Delivers Structured Product Labeling (SPL) Services for FDA Regulatory Compliance

Whippany, NJ (February 6 , 2006) - Image Solutions Inc., (ISI) a global technology company and a leader in providing software solutions and services for electronic regulatory document submission and clinical trials management, announced today that they will provide Structured Product Labeling (SPL) conversion services for pharmaceutical companies to meet FDA requirements.


The technology that is used by ISI has been used in over 100 label conversions to date and provides a direct conversion between traditional word-processed labels and the XML-based Structured Product Labeling. Peggy Boe, Director of Medical Writing and leader of ISI's SPL Project, is quoted as saying, "Companies can continue to maintain their labels in Microsoft® Office Word, with the full knowledge that the conversion to SPL performed by ISI will be complete, fast, and accurate, without the concerns associated with copying text into an XML document. When used in combination with ISIWriter™ (ISI's regulatory document template software), the conversion process is even simpler, as ISIWriter provides a well-structured basis on which to build the SPL document."

Joel Finkle, Director of Product Strategy, stated, "Combined with ISI's reputation for quality assurance and knowledge of regulatory submissions and medical writing, ISI can now provide label conversions, whether it's a single label for inclusion in a new regulatory filing, or conversion of the hundreds of existing labels a large pharmaceutical company will need to perform to comply with the latest regulations."

ISI's service offerings include one-time conversion, a subscription to update all changes over the course of a year, knowledge-based quality control checks, and consultative services to help pharmaceutical companies prepare their labels for conversion.

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 firm to deliver electronic submissions to the industry and since has delivered thousands of submissions. The company has a 49 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 recognized charitable organisations. For more information, visit the company website at:
www.imagesolutions.com.

 
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