Introducing HAQ Manager

Weave Bio’s HAQ Manager supports regulatory teams as they manage Health Authority Questions and related eCTD content across the regulatory lifecycle.

Effortless collaboration. Instant answers. Unified transparency.

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HAQs are make-or-break in drug development.

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 Rice
Brandon Rice Co-Founder and CEO of Weave

How It Works

Weave Bio’s HAQ Manager works by extracting individual questions, identifying relevant source files from your Data Room, populating metadata, and generating draft responses—helping reduce 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.

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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.

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*Based on a 2022 survey by Indegene

HAQ Manager is part of the broader Weave Bio platform. To learn more or connect with the team, contact Weave Bio.

Learn more about Health Authority Questions through the U.S. Food and Drug Administration (FDA).

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Drafts in minutes. It sounds impossible until you see it.

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