Reed Tech combines its leading-edge data conversion and content management capabilities to meet the needs of Life Sciences manufacturers in complying with today’s Structured Product Labeling (SPL) requirements.
Converting your current drug product labels into XML format is the first step in the SPL process. The next step involves placing your XML-formatted information into the compliant SPL structure. In addition to the actual conversion, the application of FDA business rules, label validation, and content management present a significant and complex challenge to the entire conversion process, taking it beyond a simple cut and paste exercise.
Given the many challenges of the SPL process, converting your current product label into compliant SPL is best done by professionals who are not only experienced in transforming large volumes of data into usable information and maintaining it thereafter, but also extremely well-versed in the FDA regulations surrounding the validity and acceptance of your label in a timely fashion. Moreover, you will find the cost of outsourcing your label conversions is less than the costs of performing your own conversions in-house because you don’t have to worry about purchasing and maintaining software, training and retaining in-house staff, or staying on top of the many changes made by the FDA to the SPL regulations. Reed Tech’s SPL Conversion solution allows you to focus on other regulatory matters while we take care of your drug label for you.