Weave, in collaboration with Takeda, has published a first-of-its-kind study — Human–AI Collaboration Increases Efficiency in Regulatory Writing.

The study compared traditional regulatory drafting with AI-augmented drafting on the Weave Platform. Key findings include:

• ~97% reduction in first-drafting time — from ~100 hours to as little as 2.6–3.7 hours for large IND nonclinical written summaries
• No critical regulatory errors identified in AI-generated drafts during independent QC assessments
• Opportunities for refinement in clarity and conciseness, highlighting the continued importance of expert human reviewers

These results reflect Weave’s philosophy: AI accelerates, but human expertise ensures accuracy. Every document is guided and finalized by regulatory experts to meet the highest standards of quality.

Complete the form to download your copy from Weave or view online at https://arxiv.org/abs/2509.09738.

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.

Artificial Intelligence (AI) is transforming industries, and drug development is no exception. The regulatory lifecycle, a critical part of therapeutic drug development, offers numerous opportunities for AI to streamline processes, reduce errors, and accelerate time to market.How do you effectively incorporate AI into this complex lifecycle? It requires a thoughtful approach and a clear framework to ensure success, which we present here as five key elements.