Business Services Industry
Reed Technology and QeL Team to Provide SPL-PLR Services for Pharmaceutical Manufacturers; Newly Mandated FDA Requirements Available From One Integrated Source
Business Wire, June 19, 2006
PHILADELPHIA -- Reed Technology and Information Services Inc. and Quadrant eLabeling Services LLC today announced that they are teaming to provide pharmaceutical manufacturers with integrated Structured Product Labeling - Physician Labeling Rule (SPL-PLR) services.
Since November 2005, pharmaceutical manufacturers have been required to submit their drug product labeling information to the FDA in an XML format known as Structured Product Labeling (SPL). The FDA has recently announced that New Drug Applications, Biologics License Applications and Efficacy Supplements submitted after June 30, 2006 are required to conform to the SPL-PLR format. In addition, all NDAs, BLAs and Efficacy Supplements approved since June 30, 2001 must change to the SPL-PLR format during a scheduled 7-year implementation plan.
The Physician Labeling Rule (PLR) has added numerous challenges to Structured Product Labeling submission requirements. New content, new structure and new Highlights information have added a higher level of complexity to the original SPL creation process.
To provide pharmaceutical companies with a high quality, easy to use solution to meet their SPL-PLR challenges, Reed Technology, a leading provider of high quality SPL conversion services and a member of the ThinSpring Team, and QeL, a leading provider of PLR Highlights Structuring and Coding guidance and assistance have teamed to provide Highlights information in an integrated fashion to Reed Tech's and the ThinSpring Team's many pharmaceutical customers. These customers include proprietary and generic manufacturers, large and small.
"Reed Tech's teaming with QeL offers our SPL conversion customers the opportunity to have the highest quality Highlights information, including creation of Highlights Text and development of Highlights Codes, prepared by QeL's subject matter experts, including Drs. Leander Fontaine and Sidney Kahn," said Mark Bayer, Vice President, Business Development, Reed Tech.
"By teaming with Reed Tech, QeL will provide Reed Tech's and the ThinSpring Team's customers with an integrated, high quality capability to meet their PLR requirements," said Jack Todes, President, QeL. "The combination of QeL's PLR clinical knowledge and experience coupled with Reed Tech's high quality SPL conversion services creates a "win" for the pharmaceutical community."
The ThinSpring Team, comprised of Reed Tech and ThinSpring, provides a full range of SPL solutions from quality outsourced conversion services today to a powerful internally implemented software solution tomorrow. ThinSpring (www.thinspring.com) is a leading provider of XML-based solutions such as SPL Server(TM) and the FDA's Electronic Labeling Information Processing System (ELIPS).
About Reed Technology and Information Services Inc.
Reed Technology, based outside Philadelphia, creates integrated document and content processing solutions that are designed to fit the distinct needs of clients in both the government and commercial sectors. The company's service suite includes all facets of information capture, transformation, life cycle management and distribution of large volumes of technical and complex documents with a commitment to accuracy, quality and customer service. Reed Tech has provided the U.S. Patent and Trademark Office with services supporting publication of U.S. patent grants since 1970 and U.S. patent applications since 2001. Reed Tech provides electronic document management solutions to the pharmaceutical industry and other government customers. For more information, visit http://www.ReedTech.com. Reed Tech is a member of the LexisNexis Group (http://www.lexisnexis.com), a leading provider of information and services solutions, including its flagship Web-based Lexis(R) and Nexis(R) research services.
About Quadrant eLabeling Services LLC
QeL (www.QeLabeling.com), based in the Philadelphia suburbs, was established in 2005 specifically to provide SPL services to the Pharmaceutical Industry. Since May 2006, QeL's SPL focus has been exclusively on providing Highlights Structuring and Coding guidance and assistance to clients. The company also conducts workshops and seminars focusing on the Physician Labeling Rule and SPL. QeL brings together an outstanding set of resources uniquely qualified to provide these services. The Highlights Structuring and Coding and corresponding quality assurance provided by QeL are designed and performed by recognized pharmaceutical experts with the support of highly skilled IT professionals.
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