HAQ Manager

Weave Bio's HAQ Manager is a regulatory software solution designed to support pharmaceutical and biotech teams in managing Health Authority Questions (HAQs) and related eCTD content across the regulatory lifecycle. Built and tested with direct input from a top-20 pharma company, HAQ Manager is purpose-built for regulatory, clinical, CMC, and nonclinical teams who face tight deadlines and high-volume question sets from agencies such as the FDA and EMA.

Health authority questions can arrive in the hundreds at once, with response windows as short as 24 hours. HAQ Manager addresses this challenge by automating the administrative complexity of the response process—extracting questions with 100% precision at 99.7% recall across sample question files—so that regulatory teams can respond decisively without sacrificing quality or accuracy.

How HAQ Manager Works

• Automatically extracts individual questions from incoming health authority requests
• Identifies relevant source files from the organisation's Data Room
• Populates metadata associated with each question to reduce manual errors
• Generates draft responses in minutes, covering narrative, tabulated, and other structured content formats
• Compiles all responses automatically into a single response document, formatted directly into the 1.11 section
• Allows users to add questions, assign field values, or override generated content at any time to guide and refine responses

Key Capabilities

• Speed at scale: Handles unstructured requests in minutes instead of weeks, enabling teams to meet even the most demanding regulatory deadlines
• High extraction accuracy: Achieves 100% precision and 99.7% recall when extracting questions from FDA and EMA sample files
• Cross-functional collaboration: Unites regulatory, clinical, CMC, and nonclinical teams within a single shared workspace, with the ability to assign subject matter experts (SMEs) to author and review individual questions
• AI-assisted drafting: Leverages AI to generate ready-to-submit responses while keeping human reviewers in full control of the final output
• Linked source verification: Provides an expanded preview to compare response details side by side with original source content, including related questions and previous answers to similar questions, ensuring every response is grounded in trusted data

Efficiency and Time Savings

• Estimated savings of between 500 and 3,500 hours per year, per application, based on a 2022 survey by Indegene
• Reduces the manual burden of organising source content, managing metadata, and drafting responses
• Enables regulatory teams to maintain quality and precision even under extreme time pressure

HAQ Manager is part of the broader Weave Bio platform, which is designed to transform how regulatory work flows across the drug development lifecycle. Teams looking to streamline their health authority interactions and reduce response turnaround times can contact Weave Bio directly to schedule a demo or learn more.