ThinSpring’s ELIPS Technology Solution Achieves Critical FDA E-Submissions’ Milestone

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ThinSpring, a leading provider of XML-based solutions and developer of SPL Server provides the technology at the heart of ELIPS. This milestone paves the way for the Structured Product Labeling (SPL) mandate to become a reality later this year as directed by the FDA.

The solutions implementation team for the Food and Drug Administration’s (FDA) Electronic Label Information Processing System (ELIPS) completed the first XML-based labeling submission to the National Library of Medicine (NLM) recently. This successful submission included the conversion of a drug label to Structured Product Labeling (SPL) XML, using SPL Server™ in the conversion process, by ThinSpring’s conversion services partner, Reed Technology and Information Services.

ThinSpring, a leading provider of XML-based solutions and developer of SPL Server provides the technology at the heart of ELIPS. This milestone paves the way for the Structured Product Labeling (SPL) mandate to become a reality later this year as directed by the FDA.

According to Ron Celeste, CEO of ThinSpring, “The FDA is really breaking new ground with ELIPS. By ensuring rapid label-change approvals and immediate electronic distribution to medical professionals and consumers, critical labeling information can be conveyed accurately and quickly, improving medical outcomes and reducing the chance for prescribing errors.”

The same technology being implemented by the FDA is available commercially to pharmaceutical companies for label submissions management and validation of SPL submissions. “ThinSpring’s dedication to customizing an effective SPL solution and 100% assured SPL compliance is a winning combination for a wide-range of pharmaceutical companies,” states Kevin Stapel, Chief Technology Officer, and developer of ThinSpring’s patented XML engine. “When ThinSpring’s SPL Server is used to convert, manage and submit labeling content, it is certain that the label will pass the FDA’s XML validation process and business rules review.”

Mr. Celeste concludes, “Overall, the benefit to pharmaceutical companies is substantial. When a company needs to get a label approved, or revisions implemented, they can’t worry about technology issues. ThinSpring’s SPL Server allows their focus to remain on labeling content, and not the technology. Everyone benefits: the company, the FDA, and the patient!”

SPL Server and conversion services based on SPL Server are available today. The ELIPS technology implementation project is on-track and scheduled for completion on October 31, 2005. Further information about the ELIPS project or SPL Server can be obtained from Mr. Celeste at ron.celeste@thinspring.com.

About ThinSpring:

ThinSpring, founded by former pharmaceutical and medical device professionals, specializes in XML-based Web service solutions, integration and data conversion. ThinSpring has used its industry expertise to develop a dynamic XML engine, MatriXML™. This patented XML technology is the basis for SPL Server™. ThinSpring’s solutions have gained acceptance as an essential, collaborative application-development platform for FDA regulated companies. ThinSpring’s core team manages technology and regulatory consulting divisions that support its clients’ worldwide operations. ThinSpring is headquartered in Corona California, with offices in New Jersey and North Carolina. More information about ThinSpring and ThinSpring’s SPL Server™ can be found on their website at: http://www.ThinSpring.com.

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Shaun Williams
THINSPRING
908-595-2145
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