US Labeling

US Labeling

For pharmaceutical companies that market products in the United States, the FDA requires the submission of product information documents, including labeling, in the Structured Product Labeling (SPL) format made possible by Extensible Markup Language (XML). SPL Portal, from Intagras, enables the standardization and harmonization of produt label creation and modification under the FDA-mandated guidelines. With XML at the core of our robust product label software, your organization experiences significant time- and cost-savings in this key functional area. Ensuring that your labeling is accurate and FDA compliant is also a crucial step in rolling out your new or improved pharmaceutical precuts to the marketplace.
 
The power of SPL Portal ensures that redundant labeling efforts are eliminated. Additionally, the global tracking and control of concurrent submissions is enhanced. All modifications to product core data sheets are reflected across your network of affiliates, no matter how many there are, or where they may be located. SPL Portal automates key process steps such as the review, approval and distribution of your product-related documentation. And, as always, the superlative support and services of Intagras are just a call away for FDA regulatory guidance. 
 
Find out how the power of SPL Portal can impact your organization in positive ways, and ensure you are always compliant with FDA labeling regulations and guidelines, by calling (813) 226-1863 to schedule a demonstration.