regulatory medical writing
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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 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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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 ICH Guidelines: E3, E6, and E8 from a Medical Writer’s Perspective By ‘Femi Fajimi | 05 May 2025 Becoming confident in regulatory medical writing involves more than understanding clinical content; it also means becoming familiar with the guidelines that shape how studies are conducted and reported. The International Council for Harmonisation (ICH) issues
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Clinical Trial Protocols and Clinical Study Reports (CSRs): A Beginner’s Perspective By Femi Fajimi | 28 April 2025 As I continue developing my skills in regulatory medical writing, I am learning how essential two key documents are to the clinical trial lifecycle: the protocol and the clinical study report (CSR). Protocols define a study’s blueprint,
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Starting Somewhere By Femi Fajimi | 21 April 2025 Every journey begins somewhere, and for me, this is it.Welcome to my blog. I’m a healthcare professional with a medical, public health, and oral health education background. Over the years, I’ve worked in both clinical and community-based roles, but what has remained consistent is my interest
'Femi Fajimi 