New capability brings proven AI automation to Health Authority Question responses—accelerating timelines during the most time-sensitive phase of the regulatory approval process

Weave Bio, the leader in AI-native regulatory automation, today announced the launch of HAQ Manager, a breakthrough capability that applies artificial intelligence (AI) and workflow automation to accelerate responses to Health Authority Questions (HAQs) during regulatory review. This launch extends Weave's platform beyond submission preparation into the critical post-submission review phase, helping organizations navigate one of the most time-pressured and consequential stages of drug development.

The announcement follows Weave's recent $20 million Series A funding round and represents a significant step in the company's expanding roadmap to support the full regulatory lifecycle. Developed in close collaboration with Takeda Pharmaceuticals, HAQ Manager addresses one of the industry's most pressing bottlenecks: responding to agency questions under extreme time pressure while maintaining quality, consistency, and compliance.

"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."

When the Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities issue questions during their review—often dozens of complex queries at once—companies typically have just days to weeks to respond. Yet teams must coordinate across technical, operational, and regulatory functions, synthesize data from myriad sources, and ensure consistency with previously submitted materials. Inadequate responses can delay approval by months, while rushed responses risk inconsistencies that may undermine regulatory confidence.

“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," said Andrew Robertson, Vice President and Head of Global Regulatory Policy and Innovation at Takeda. "We partnered with Weave to make that process more efficient and to help us move faster with regulatory agencies to get our products reviewed. It has been excellent to see the capabilities develop while working so closely with the Weave team to design the workflow.”

Integrated directly into The Weave Platform, HAQ Manager automatically extracts and tracks incoming questions, generates draft responses based on relevant source documentation and historical regulatory interactions, and consolidates responses across teams for the final submission. Intelligent workflow automation maintains version control, tracks progress across teams, and ensures alignment between functions—creating a connected environment where teams can collaborate in real time and deliver responses that reflect both institutional knowledge and current program data.

HAQ Manager joins Weave's expanding suite of regulatory automation tools, which includes support for submissions spanning preclinical to clinical. The platform has been widely adopted across biotech, pharmaceutical companies, CROs, and regulatory consultants, earning recognition as the "Biotech AI Innovation of the Year". It accelerates regulatory timelines by more than 50% while reducing costs and improving review quality.

With HAQ Manager now covering the post-submission review phase, Weave continues to build toward its vision of comprehensive regulatory lifecycle support—with planned expansions into New Drug Applications (NDAs) and Biologics License Applications (BLAs), postmarket filings, and global markets including Europe, Japan, and Latin America.

HAQ Manager is available now for new and existing Weave Platform customers.

For more information, visit weave.bio or contact Info@weave.bio.

About Weave Bio

Weave Bio is an AI-native software company transforming how novel therapies navigate the complex path from lab to market. The Weave Platform streamlines regulatory content preparation and lifecycle management for pharmaceutical companies, biotech firms, CROs, and regulatory consultants by infusing AI into every step of the workflow—from data extraction and authoring to review and verification—yielding compliant, submission-ready regulatory dossiers with unprecedented speed.

The Weave Platform has been widely adopted for preclinical IND preparation and earned industry recognition as the "Biotech AI Innovation of the Year" award winner. Weave has since expanded to support clinical-stage submissions, delivering a comprehensive AI workbench that accelerates regulatory timelines by more than 50% while improving review quality and ensuring compliance with FDA, EMA, and global regulatory standards.

Founded in 2022 and headquartered in San Francisco, Weave Bio bridges regulatory expertise, AI innovation, and enterprise software to solve critical bottlenecks in drug development. Backed by leading investors including USVP, Innovation Endeavors, Magnetic Ventures, Character, TMV, and Serrado Capital, and trusted by innovative biopharma companies worldwide, Weave is building the new standard in regulatory automation.

For more information, visit weave.bio and follow us on LinkedIn.

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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.