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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.

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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.

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