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Structured Product Labeling
Structured Product Labeling (SPL)

Pharmaceutical label tracking helps to ensure that only the highest quality drugs are produced and distributed to the public.

Pharmaceutical Label Tracking
Pharmaceutical Label Tracking

Pharmaceutical label tracking helps to ensure that only the highest quality drugs are produced and distributed to the public.

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.