Early-career medical writer
-
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
-
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)