Health authority questions (HAQs) come fast, sometimes hundreds at once—with answers expected in as little as 24 hours.
With Weave’s HAQ manager, responses are generated in minutes with unmatched accuracy. Built and tested with direct input from a top-20 pharma company, Weave extracts questions with 100% precision at 99.7% recall when tested across sample question files from the FDA and EMA.
When health authorities have questions, every minute counts. By automating the administrative complexity and surfacing the right information at the right time, HAQ Manager gives regulatory teams the speed and confidence they need to respond decisively, while maintaining the quality and precision these critical interactions demand.
Brandon RiceCo-Founder and CEO of Weave
How it works
Your HAQ Manager automatically extracts individual questions, finds relevant source files from your Data Room, populates metadata and generates draft responses—eliminating manual errors
While HAQ handles the heavy lifting, you stay in control. Need to add questions or guide new responses? Just assign or override field values at any time to produce the answer you need, automatically compiled into a single response document.
Meet impossible deadlines
Handle unstructured requests in minutes instead of weeks. Weave produces responses of every kind—narrative, tabulated or other structured content—directly in your 1.11 section.
Collaborate across functions
Unite regulatory, clinical, CMC and nonclinical teams in one shared workspace. Assign the right SMEs to author and review each question, collaborating with colleagues and leveraging AI for ready-to-submit responses.
Link with confidence
Use the expanded preview to compare details side by side with the original, including any related questions or previous answers to similar questions, to ensure every response with trusted data.
Save between 500 and 3,500 hours per year, per application*
Brandon Rice Co-Founder and CEO of Weave
