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Writing Lay Summaries: What I Didn’t Expect to Learn as a Regulatory Writer By Femi Fajimi | 27 November 2025 (Educational content. No confidential information included.) Introduction When I started learning regulatory medical writing, I assumed that lay summaries were “scientific findings rewritten in simpler language.” I expected the usual tasks: reducing jargon, shortening sentences,
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From “Raw TFLs” to Regulator-Ready Narratives: A Medical Writer’s Walkthrough (Antifungal Case Study) By Femi Fajimi | 10 September 2025 (Educational content. Drug, data, and outputs below are fictional but formatted to mirror real deliverables.) Introduction Sometimes, when I am asked to support some freelance writers with their ongoing projects, particularly when it involves reviewing
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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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Writing Clinical Overviews and Clinical Summaries in Regulatory Submissions: A Regulatory Writing Walkthrough with Oncometherin By Femi Fajimi | 26 July 2025 (Educational content. Oncometherin is a fictional investigational product.) Introduction: Clinical Modules at the Heart of Regulatory Submissions Regulatory medical writers play a pivotal role in preparing the documentation that supports new medicine applications.
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Understanding Development Safety Update Reports (DSURs): A Dermalexiin Case Study By Femi Fajimi | 16 July 2025 Introduction: The Role of DSURs in Clinical Drug Development In clinical development, the safety of trial participants is of paramount importance. To ensure that investigational products are being evaluated responsibly, regulatory authorities require annual safety updates that provide
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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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The Investigational Medicinal Product Dossier (IMPD): An Overview from a Developing Medical Writer By Femi Fajimi | 23 June 2025 Regulatory medical writing requires a blend of scientific insight, structured communication, and regulatory awareness. As a developing writer, I’ve come to realise that the work extends beyond writing well; it’s about presenting data, safety, and
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Writing Safety Updates in Regulatory Medical Writing: An Overview of RMPs, DSURs, PADERs, and PBRERs from a Developing Writer’s Perspective By ‘Femi Fajimi | 13 July 2025 One of the most critical responsibilities in regulatory writing is preparing safety documents that monitor, assess, and communicate drug safety throughout its lifecycle. These documents help regulatory authorities
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Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol
Understanding the Paediatric Investigation Plan (PIP): How It Differs from a Clinical Trial Protocol By Femi Fajimi | 02 June 2025 Introduction When I first heard the term Paediatric Investigation Plan (PIP), I assumed it was just a clinical trial protocol for children. But I soon realised it’s a much broader regulatory tool, one that
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'Femi Fajimi 