When evaluating content—whether produced by humans or AI—it is crucial to adopt a systematic and structured approach to ensure an objective and consistent assessment.

We have identified several categories that encompass the key aspects of technical writing for regulatory submissions related to therapeutics.Within each category we provide example metrics and a scoring rubric to promote consistency across reviewers. While these example metrics are not exhaustive and may not apply directly to all types of content(e.g., CMC), they are intended to be semi-quantitative and explainable.This rubric is most effective when applied to the smallest logical “unit”of writing, such as an individual study summary, and measured for numerous examples.