Bridgewater, NJ (PRWEB) December 21, 2006
ThinSpring, a leading provider of XML-based solutions such as SPL Server™ and the FDA's Electronic Labeling Information Processing System (ELIPS), announces the release of XMLSage 3.0 with support for the Physician Labeling Rule (PLR) for Structured Product Labeling (SPL) using SPL Server. This upgrade represents the ongoing commitment that ThinSpring has to giving its customers a software product that guarantees seamless and effortless regulatory compliance.
"This advance in technology is one representation of how ThinSpring provides regulatory compliance software that is totally aligned with the current state of affairs within regulatory organizations world-wide," said Ron Celeste, President and CEO of ThinSpring. "Our unique ability to be in touch with the inside track of regulatory agencies around the world is one of the enabling factors to our leading the industry in regulatory compliance software and services."
Federally Mandated PLR Requirements
Bound by federal mandate, the United States Food and Drug Administration (FDA) has required that all NDAs, BLAs, and Efficacy Supplements submitted after June 30, 2006 conform to the SPL-PLR rule. In addition, all NDAs, BLAs, and Efficacy Supplements approved since June 30, 2001 must be converted to the SPL-PLR format in the course of a 7-year implementation window.
What's New With PLR?
Some new elements have been added as a result of the PLR mandate including the Highlight Text section, table of contents, expanded codes, more medical terms, more reference tables, appended patient labeling, and Full Prescribing Information (FPI). All of the ThinSpring Team software and services are designed for complete compliance with the new SPL-PLR requirements.
The ThinSpring Solution
The FDA currently uses ELIPS as a part of the process to receive, internally validate, store, approve and transmit SPL submissions from pharmaceutical manufacturers. From the experience of developing ELIPS, ThinSpring is able to provide effective and reliable XML submission and structured data management solutions. The ThinSpring solution is world-class architecture supported by the best and most experienced subject matter experts in the industry.
For more information, go to the ThinSpring website or contact Earl Pendleton at (919) 654-4535.
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' 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 SPL Server™ can be found on their website at: http://www.ThinSpring.com.