Weave Bio Launches HAQ Manager with Takeda to Extend AI Automation into Regulatory Review

Weave Bio, a San Francisco-based company specializing in AI-native regulatory automation, has introduced HAQ Manager to streamline and accelerate the process of responding to Health Authority Questions (HAQs) during regulatory review. The tool expands the company’s automation capabilities into the post-submission phase, helping pharmaceutical and biotechnology organizations manage one of the most time-pressured and consequential parts of the approval process.

HAQ Manager was developed in collaboration with Takeda Pharmaceuticals and builds on Weave’s AI-driven platform used for regulatory submission preparation. The new capability automatically extracts, tracks, and manages incoming HAQs from authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). It generates draft responses based on relevant source documents and prior submissions while maintaining version control, tracking progress, and ensuring cross-functional consistency.

“HAQ Manager brings the same AI-driven efficiency our customers rely on for submissions to one of the most complex—and consequential—phases of the regulatory lifecycle,” said Brandon Rice, Co-Founder and CEO of Weave Bio. “When health authorities have questions, every hour 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.”

Andrew Robertson, Vice President and Head of Global Regulatory Policy and Innovation at Takeda, noted the benefits of the collaboration: “Responding to Health Authority Questions is one of the most stressful phases of drug development—you’re juggling dozens of data sources from multiple teams, manual processes, and tight deadlines. We partnered with Weave to make that process more efficient and to help us move faster with regulatory agencies to get our products reviewed.”

The launch follows Weave Bio’s $20 million Series A funding round and supports its roadmap to cover the full regulatory lifecycle. HAQ Manager joins a suite of tools designed to automate workflows from preclinical through clinical stages, reducing timelines by over 50% while improving quality and compliance. The company plans future expansions into New Drug Applications, Biologics License Applications, postmarket filings, and new global markets including Europe, Japan, and Latin America.

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