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Regxia Review

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

Update: Health Canada’s Guidance on Drug Submissions for Biologics

Tharshini Veerasingam

5 days ago2 min

Update: Health Canada’s Guidance on Drug Submissions for Biologics

Health Canada's updated guidance document combines three CTD guidance documents applicable to conventional biotherapeutic products into one.

Pharmacovigilance / Drug Safety Defined

Sep 122 min

Pharmacovigilance / Drug Safety Defined

Pharmacovigilance activities are necessary to ensure the detection, assessment, understanding and prevention of adverse effects.

Updates to Health Canada’s GUI-0119: Manufacture of Sterile Drugs

Aug 292 min

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.

eCTD – Why Outsource?

Aug 82 min

eCTD – Why Outsource?

eCTD is used for regulatory submissions to Health Authorities globally. Partnering with an experienced provider can streamline the process.

XML PM: What is it and why does it matter to sponsors?

Tharshini Veerasingam

May 143 min

XML PM: What is it and why does it matter to sponsors?

Health Canada's XML PM: What is it? What are the challenges? How can you prepare?

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