Medical writing education

  • Writing Briefing Documents for Scientific Advice Meetings: A Step-by-Step Guide Using Azidomyxin  By Femi Fajimi | 08 August 2025  (Educational content. Azidomyxin is a fictional investigational product.)  Introduction: What Is a Briefing Document and Why Does It Matter?  In the pharmaceutical development lifecycle, the path from laboratory discovery to patient access is highly regulated. At

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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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