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Regulatory Submission Software
What is SPL Submission Software?

Regulatory submission software takes the guesswork out of Structured Product Labeling (SPL)/Structured Product Monograph (SPM) submissions by giving you real-time validations.

Pharmaceutical Labeling
What is Pharmaceutical Labeling?

Pharmaceutical labels are mandatory for marketing and selling a drug. It’s critical for pharma companies to have a reliable way to track every difference and change, all around the world.

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Implementation Process for the Intagras Tracking Portal

Intagras’ Tracking Portal was created specifically for pharmaceutical companies by gathering requirements from around the world.

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Updating National Licenses for the EAEU

Starting in 2021, all national licenses will need to be re-registered with the Eurasian Economic Union (EAEU) by the end of 2025.

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2020 Transition Period for Brexit

Learn how to complete an impact assessment in the Tracking Portal for records directly impacted by the EMA’s guidance for the transition period in 2020.

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Swissmedic New Safety Signal Guidance

Swissmedic released guidance that introduces a timeline for the submission of labeling updates for all products with marketing authorization in Switzerland.