Regulatory submission software takes the guesswork out of Structured Product Labeling (SPL)/Structured Product Monograph (SPM) submissions by giving you real-time validations.
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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.
Intagras’ Tracking Portal was created specifically for pharmaceutical companies by gathering requirements from around the world.
Starting in 2021, all national licenses will need to be re-registered with the Eurasian Economic Union (EAEU) by the end of 2025.
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.