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Regxia Review

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

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

Aug 29
2 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 8
2 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 14
3 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?

Regulatory and Medical Writing, A Consultant’s Perspective – Part 7 – Last Words

May 8
3 min

Regulatory and Medical Writing, A Consultant’s Perspective – Part 7 – Last Words

Regulatory and Medical Writing advice from a expert regulatory consultant.

Regulatory and Medical Writing, A Consultant’s Perspective – Part 6 – Interpretation

May 8
2 min

Regulatory and Medical Writing, A Consultant’s Perspective – Part 6 – Interpretation

Regulatory and Medical Writing advice from a expert regulatory consultant.

Regulatory and Medical Writing, A Consultant’s Perspective – Part 5 – Tables and Figures

May 8
2 min

Regulatory and Medical Writing, A Consultant’s Perspective – Part 5 – Tables and Figures

Regulatory and Medical Writing advice from a expert regulatory consultant.

Regulatory and Medical Writing, A Consultant’s Perspective – Part 4 - Narratives

May 8
3 min

Regulatory and Medical Writing, A Consultant’s Perspective – Part 4 - Narratives

Regulatory and Medical Writing advice from a expert regulatory consultant.

Regulatory and Medical Writing, A Consultant’s Perspective – Part 3 - Format

May 8
2 min

Regulatory and Medical Writing, A Consultant’s Perspective – Part 3 - Format

Regulatory and Medical Writing advice from a expert regulatory consultant.

Regulatory and Medical Writing, A Consultant’s Perspective - Part 2 – Audience

May 8
3 min

Regulatory and Medical Writing, A Consultant’s Perspective - Part 2 – Audience

Regulatory and Medical Writing advice from a expert regulatory consultant.

Regulatory and Medical Writing, A Consultant’s Perspective – Part 1 – Introduction

May 8
3 min

Regulatory and Medical Writing, A Consultant’s Perspective – Part 1 – Introduction

Regulatory and Medical Writing advice from a expert regulatory consultant.

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