Regxia Review
Welcome to the Regxia Review. Your go-to resource for regulatory and quality insights.
Are you ready for Health Canada's mandatory XML PMs?
Update: Health Canada’s Guidance on Drug Submissions for Biologics
Pharmacovigilance / Drug Safety Defined
Updates to Health Canada’s GUI-0119: Manufacture of Sterile Drugs
eCTD – Why Outsource?
XML PM: What is it and why does it matter to sponsors?
Regulatory and Medical Writing, A Consultant’s Perspective – Part 7 – Last Words
Regulatory and Medical Writing, A Consultant’s Perspective – Part 6 – Interpretation
Regulatory and Medical Writing, A Consultant’s Perspective – Part 5 – Tables and Figures
Regulatory and Medical Writing, A Consultant’s Perspective – Part 4 - Narratives
Regulatory and Medical Writing, A Consultant’s Perspective – Part 3 - Format
Regulatory and Medical Writing, A Consultant’s Perspective - Part 2 – Audience
Regulatory and Medical Writing, A Consultant’s Perspective – Part 1 – Introduction