We are developing a range of instructor-led and digital training modules covering essential regulatory documents.
Our training modules will offer the opportunity to work on real-life simulated projects to hone your regulatory writing skills.
A comprehensive introduction to the field of medical writing, covering the drug development process, and the role of medical writers in clinical and regulatory documentation and submissions
The essential skills for effectively writing clinical, regulatory, and pharmacovigilance documents to ensure clarity, quality, and compliance with industry standards
Introduction to the components of a CSP, regulatory guidelines for protocol development, and essential steps in the preparation of high-quality CSPs, with hands-on exercises and detailed feedback
The essential skills for the preparation of high-quality CSRs and management of the CSR writing process, including hands-on exercises and detailed feedback
Introduction to the purpose, structure, and content of PBRERs, focusing on safety data analysis, benefit-risk evaluation, and safety signal detection
Introduction to the purpose, structure, and components of DSURs, focusing on safety data analysis and benefit-risk evaluation
Sign up to be notified when our training guides are available
© 2025 Mosaic Medical Writing. All Rights Reserved