Structured Product Labeling (SPL)

US Labeling Challenges

In the United States, pharmaceutical, over-the-counter, biotech and animal healthcare companies are required to submit product information documents, National Drug Code (NDC) labeler requests, and establishment registrations to the Food and Drug Administration (FDA) in an Extensible Markup Language (XML) format called Structured Product Labeling (SPL).

The system enables authorized users to manage the document properties for updating information, re-generating and re-submitting submissions in SPL format to the Agency. For manufacturers, benefits of standardizing under SPL, with XML at its core, include error reduction (as documents do not need to be re-created), dramatic time and cost savings and faster new product rollouts.

Since life sciences companies face multiple global labeling requirements, companies can benefit from scalable, flexible systems that ensure ongoing compliance with evolving global labeling standards.

Glemser's SPL Solutions and Services

Glemser’s xmLabeling for SPL is a global content management system that addresses all FDA requirements for submitting labels in SPL format. Several global pharmaceutical companies currently use xmLabeling in production to manage their labeling content. With our comprehensive document management functionality, your company can eliminate redundant content, improve global tracking and control parallel submissions. It also ensures that core product changes are reflected in all applicable global labeling documents and automates processes for document review, approval and distribution. Skilled Glemser consultants are available to help with all phases of your project. We deploy our out-of-the-box SPL solution using best-practice configurations and accelerated implementation strategies for your system development lifecycle (SDLC) deliverable.