This site uses modern web standards that aren't supported by your browser. For best results, please upgrade to Google Chrome, Microsoft Edge, or Mozilla Firefox.

Rx, OTC and Biologics Compliance and Regulatory

Meet regulatory mandates with confidence.

Ease the burden of compliance with accurate electronic submission of drug product data to regulatory authorities.

Structured Product Labeling (SPL) for Drug and Biologic Products

Transform your product data

Fulfill the FDA electronic submission mandates for Drug Listing, Lot Distribution Reports, Establishment Registration and other SPL submissions in a process that offers simplicity, accuracy and support from Structured Product Labeling experts.

Learn More

SPL-Driven Composition Process

Capitalize on your investment in SPL

Compose promotional materials directly from the Content of Labeling already accepted by the FDA to increase accuracy, lower risk and reduce cost.

Learn More

By continuing to use the site, you agree to the use of cookies. more information

The cookie settings on this website are set to "allow cookies" to give you the best browsing experience possible. If you continue to use this website without changing your cookie settings or you click "Accept" below then you are consenting to this.