regulatory writing
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Understanding Pre-Clinical Modules of the CTD – A Dermalexiin Case Study By Femi Fajimi | 02 July 2025 Introduction: The CTD and Its Pre-Clinical Modules Regulatory medical writers often encounter the Common Technical Document (CTD) format when preparing submissions for new medicines. The CTD is organised into five modules, where Module 4 compiles all pre-clinical (nonclinical)
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Writing Patient Narratives in Clinical Trials: A Beginner’s Guide By Femi Fajimi | 22 April 2025 When I started exploring regulatory medical writing, one document type I kept coming across was the patient narrative. At first, I thought it would be a simple case summary, but I quickly discovered that writing a good narrative is