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

Corona, CA & Bridgewater, NJ - (November 1, 2005) - The Food and Drug Administration’s (FDA) Electronic Label Information Processing System (ELIPS) team has received the first XML-based labeling submission from the pharmaceutical industry. The FDA plans to make this label available through the National Library of Medicine’s (NLM) website, during the next month. 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 internal 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 drug safety labeling content, and not the technology. Everyone benefits: the drug manufacturer, the FDA, the medical practitioner and the patient!”

SPL Server is available today. The ELIPS technology implementation project is on-track and receiving SPL as of October 31, 2005. For more information contact Ron Celeste at ron.celeste@thinspring.com.

About ThinSpring:
ThinSpring, founded by former pharmaceutical and medical device professionals, specializes in XML web-based 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 all ThinSpring solutions including XML Sage, SPL Server, PIM Server, and eCTD 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’ operations throughout the United States, Europe, Asia and South America. ThinSpring headquarters is in Bridgewater, New Jersey, with offices in California and North Carolina. More information about ThinSpring and ThinSpring’s solutions can be found on their website at: http://www.ThinSpring.com.

Media Contact:
Ron Celeste
ThinSpring
908-962-0740
ron.celeste@thinspring.com