Thomson delivers product labeling solution

Thomson Scientific & Healthcare announced its solution to meet the Structured Product Labeling (SPL) challenge. Thomson will enable pharmaceutical companies to submit labeling and immediately go to market with labeling in the impending FDA-required format. Thomson Scientific & Healthcare is part of The Thomson Corporation.

By mid-to-late 2005, the FDA wants to timely and accurately receive prescription product labeling electronically in XML format to help improve patient safety. To ensure compliance, life sciences companies face new challenges, including converting existing labeling to SPL format, producing new labeling in SPL format, and managing the information at a much greater level of detail.

To address the challenges faced by their customers, Thomson offers these unique solutions - outsourced label conversion using Liquent Direct and transformation and lifecycle management technology via Liquent InSight Manager for Labeling. Both will support 21 CFR Part 11 compliance. “Liquent has an established history of document handling and transformation. Now, as a part of Thomson, we can work with our PDR colleagues to offer an end-to-end labeling solution from creation to dissemination of prescribing information,” said Jay Nadler, president and CEO of Liquent and senior vice-president of Thomson Scientific.

When life sciences companies turn to Liquent for SPL services, the Liquent team of regulatory experts utilizes proprietary technologies to quickly convert their labels into the standard format. Once converted and checked for accuracy, companies can then go through their normal quality assurance and approval cycles.

‘‘Our clients are acutely aware of the challenges they face by having to convert well established processes for labeling development, review and approval,’’ continued Nadler. ‘‘Our history of document management, coupled with a team of regulatory content experts, uniquely positions us to offer solutions to our clients that help them achieve their goals while allowing them to keep their current processes in place.’’

Getting the labeling converted, approved, and organized is only the first step of the Thomson solution for product labeling. Over the past several years, Thomson PDR has been actively involved with the FDA and the industry in the development and implementation of SPL standards. Thomson PDR helps life sciences companies take the next step of getting the labeling out into the hands of clinicians and the general public.

For the past six decades, PDR has been a trusted source of delivering labeling information to the pharmaceutical industry. By leveraging the Liquent conversion solutions with the Thomson PDR industry reach, Thomson ensures the life sciences industry has direct access to the necessary tools to comply with FDA labeling standards.