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Introducing Weave’s HAQ Manager: Responding to Health Authority Questions with Speed and Confidence

Friday, November 14, 2025
1:00 – 1:45PM ET / 10:00 – 10:45 AM PT

Introducing Weave’s HAQ Manager: Responding to Health Authority Questions with Speed and Confidence

Health Authority Questions (HAQs) are a routine but high-stakes part of every drug program. Managing them often means juggling spreadsheets, emails, and document versions across teams and time zones.

Join Weave for a first look at HAQ Manager, a new way to handle HAQs with effortless structure, visibility, and efficiency — all within the Weave Platform.

In this session, you’ll see how HAQ Manager helps teams stay organized, connected, and in control throughout the HAQ process — minimizing response time and ensuring nothing falls through the cracks.

HAQ Manager leverage AI to help teams:

  1. Intake, organize, and track HAQs across programs and submissions
  2. Automate response generation based off of previous answers or dossier source documents
  3. Collaborate in real time to draft and review responses
Podcast

The future of pharma – Brandon Rice and IND submission with AI

Weave Bio’s CEO and Co-founder, Brandon Rice, was recently featured on ISPE’s Future of Pharma podcast to discuss how The Weave Platform is transforming the way regulatory submissions are prepared.

In the episode, Brandon explains how our AI-native platform reduces the time it takes to generate submission-ready documents—from months of manual effort down to hours—while keeping human oversight at the center of the process. He shares insights on:

  • The bottlenecks in traditional regulatory submissions and how automation helps overcome them
  • The importance of accuracy, transparency, and human judgment in AI-assisted workflows
  • How adoption of AI in pharma varies across company size and culture
  • Global regulatory perspectives, including FDA’s growing interest in AI and EMA’s clearer guidance

Brandon emphasizes that AI is not replacing regulatory experts—it’s a powerful tool to help them work faster, with more focus on science and patients.

On demand

Elevating your regulatory workflows with the Weave platform

Reimagining Regulatory Submissions with AI-Driven Workflows

In this recorded session, Weave shares how leading sponsors are moving beyond traditional document drafting to dynamic, modular dossier construction. You’ll hear how Weave’s AI-native platform accelerates submission timelines, supports full lifecycle thinking, and gives teams more time for strategy and science.

Highlights include:
  • A step-by-step walkthrough of Weave’s platform—from source upload to dossier draft
  • Real-world results, including a 97% acceleration in authoring time with Takeda
  • A live demo: drafting a CSR from scratch in under an hour
  • How customizable AI templates support INDs, clinical submissions, and more
  • Why static documents are out—and how collaborative, traceable workflows are in

Whether you’re authoring your first IND or managing global filings, this recording offers a clear view into how Weave is helping teams rethink regulatory writing.

Watch

On demand

Draft your {blank} submission: how Weave empowers you to fill in the blank.

Regulatory Submissions, Simplified

Regulatory submissions are complex, but drafting them doesn’t have to be. What if you could generate structured, submission-ready content at the click of a button?

This webinar showcases how AI-powered templates and automation-first workflows are streamlining regulatory submissions from IND to NDA—and beyond.

What You’ll Learn:

  • How automation accelerates submission preparation – Reduce time spent on drafting and iteration from months to minutes
  • How AI-powered templates enhance content generation – Instantly produce narratives, tables, and lists beyond static document structures
  • How Weave simplifies regulatory workflows – Automate key steps from planning to publishing for greater efficiency and accuracy
  • What’s next for Weave – Expanding support for clinical-phase filings, including CSRs, protocols, and annual reports

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Podcast

AI in action podcast: how Weave is transforming regulatory submissions with AI

How is AI revolutionizing regulatory submissions in biotech and pharma? Find out in this episode of the AI in Action podcast, featuring Brandon Rice, Chief Product Officer at Weave.

Brandon shares insights on:
✔️ AI-powered automation in regulatory filings to accelerate drug approvals
✔️ Streamlining FDA submissions—cutting time and costs dramatically
✔️ Customer-driven product development for seamless compliance workflows
✔️ Expanding regulatory support from preclinical IND to clinical-stage submissions
✔️ Scaling AI-powered regulatory workbenches to support biotech, pharma, CROs, and consultants

Weave’s AI-native regulatory automation platformAutoIND, is redefining how life sciences companies prepare, manage, and submit regulatory documents. From IND to BLA, NDA, and beyond, Weave is building an AI-driven regulatory workbench for the entire therapy lifecycle.

🎧 Listen now to learn how Weave is shaping the future of regulatory automation!

Watch

On demand

AutoIND: how to expedite your path to clinical trials with an AI-native platform

What You’ll Learn:

How AutoIND Transforms Regulatory Workflows
  • Speed Up Processes – Accelerate data organization, document drafting, and content management with AI-driven automation that refines, structures, and iterates with ease.
  • Enhance Accuracy – Reduce costly errors and revisions with intelligent validation tools that ensure consistency and compliance.
  • Boost Collaboration – Foster seamless teamwork with a centralized, AI-native workbench that provides unmatched visibility and real-time communication across stakeholders.

With AutoIND, your team can move faster, work smarter, and stay focused on advancing groundbreaking science.

Watch it weave

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

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