regulatory writing

  • 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

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  • Understanding Informed Consent Forms (ICFs)  By ‘Femi Fajimi | 24 April 2025  Informed Consent Forms (ICFs) are at the heart of ethical clinical research. They represent the intersection between science, ethics, and patient communication. As I learn and grow in regulatory medical writing, I appreciate the depth and responsibility of developing these documents.  Although I’m

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