News.

Stay up-to-date on the latest regulatory trends with Intagras. Our experts provide valuable insights, strategies and tips on everything involved with regulatory tracking and submissions.

Why You Need Regulatory Tracking Software
7 Reasons Why You Need Regulatory Tracking Software in 2023

In 2023, regulatory tracking software will no longer be a luxury – it will be a necessity. Here’s how it can set you up for success.

Pharma Labeling Basics
Pharma Labeling Basics: Why It’s Essential & Who It Affects [GUIDE]

The FDA proposes a rule that would revise the National Drug Code format. What does this mean, and how may it impact you? Read on to find out.

Pharmacist
Your Guide to the Proposed National Drug Code Format Changes [2022]

The FDA proposes a rule that would revise the National Drug Code format. What does this mean, and how may it impact you? Read on to find out.

Choose Regulatory Submission Software
5 Expert Tips for Choosing Regulatory Submission Software

Creating SPL and SPM files that are compliant and error-free is key to successful submissions. Regulatory submission software can help.

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.

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Have questions about our tools or service? Talk to one of our experts or request a demo of our Tracking or SPL Portal software today.