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Regxia Review
Welcome to the Regxia Review. Your go-to resource for regulatory and quality insights.


Pharmacovigilance Compliance for Small and Mid-Sized Pharma: What You Need to Know
Pharmacovigilance (PV) compliance is more than a regulatory checkbox – it’s a commitment to patient safety.
For small and mid-sized pharma companies, staying compliant while scaling can feel overwhelming. Expensive, complex PV systems designed for Big Pharma don’t always fit the needs, or the budgets, of emerging biopharma teams. Our recent blog post, breaks down the topic and potential solutions to these challenges.
Quality Team
Jul 73 min read


Pharmacovigilance / Drug Safety Defined
Pharmacovigilance activities are necessary to ensure the detection, assessment, understanding and prevention of adverse effects.
Quality Team
Sep 12, 20242 min read


Updates to Health Canada’s GUI-0119: Manufacture of Sterile Drugs
Health Canada has updated GUI-0119 to help companies comply with GMP for fabricating and packaging/labelling of sterile drugs.
Quality Team
Aug 29, 20242 min read
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