Top 5 Common Mistakes in Clinical Module Authoring

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2025-07-01 06:13:44 -

Top 5 Common Mistakes in Clinical Module Authoring—and How to Avoid Them

Clinical module authoring plays a critical role in determining the success of a medicinal product’s approval in Regulatory submissions. Regulatory authorities worldwide rely heavily on the accuracy, structure, and clarity of Modules 2.5, 2.7, and 5 of the Common Technical Document (CTD). However, even experienced Regulatory teams can fall into common traps that delay approvals, trigger...

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