Regulatory Solutions for Small Businesses

RegAlert™ Dashboard is an advanced AI-powered intelligence dashboard designed to enhance Pharmacovigilance Risk Reporting by ensuring compliance with 🍁 Health Canada's Foreign Risk Guidance under Section C.01.050 of the Food & Drug Regulations. 

To enhance patient safety, an increasing number of regulatory authorities worldwide are implementing requirements for the timely reporting of foreign regulatory actions affecting drug substances and drug products. 

By leveraging Automated Intelligence, Natural language Processing (NLP) , RegAlert™ streamlines risk monitoring, accelerates decision-making, and enhances regulatory alignment, empowering pharmaceutical companies to stay ahead in compliance.

📖 Read the Article to see how RegAlert™ transforms regulatory intelligence into actionable insights!

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Health Canada has announced that, starting July 18, 2025, it will be mandatory to submit product monographs in Extensible Markup Language (XML) format for certain submission types, specifically New Drug Submissions (NDS) and Extraordinary Use New Drug Submissions (EUNDS) .

Actionable Items for Drug Manufacturers:

• For new drug submissions and extraordinary use submissions after July 18, 2025, include the XML PM at filing
• For generic products, wait until the Canadian Reference Product has an authorized XML PM before submitting
• For cross-licensed products, wait until the licensor’s product has an authorized XML PM before submitting
• For biosimilar products, XML PM can be submitted without waiting for the reference biologic drug
• Include package label mock-ups if aligning terminology results in labeling changes
• Complete the XML PM section of the revised Labels and Packages Certification Forms

We are in  unique position to offer the best support to drug manufacturers needing to make XML PM submissions. We have  participated in the Health Canada pilot since 2017 and supported FDA SPL since 2016.