Submission Builder

Weave Bio Submission Builder is an end-to-end AI platform purpose-built for regulatory teams preparing, organizing, and managing eCTD submission content across the full regulatory lifecycle. Designed to accelerate the journey from raw data to submission-ready packages, it supports drafting, assembling, reviewing, verifying, and publishing regulatory dossiers — reducing the time to first draft by approximately 97% compared to traditional approaches.

The platform is built for life sciences organizations working across every development milestone, from Pre-IND through post-market activities, and is validated through a partnership with Takeda, which found that Weave can compress roughly 100 hours of IND nonclinical written summaries into as little as 2.6 to 3.7 hours, with an independent QC assessment finding no critical AI-generated regulatory errors.

How Submission Builder Works: Step-by-Step Workflow

1. Draft & Iterate: Customize and populate AI templates with variables while maintaining context across iterations. Generate and refine content for Modules 1 (including Investigator Brochures), 2, 3, and 5, allowing teams to improve work over time without losing continuity.
2. Assemble: Automate submission formatting and table and figure handling, keeping citations and cross-references current — including intra-document, inter-document, and literature references.
3. Review: Collaborate live in a shared workspace where comments, context, and redline suggestions remain side-by-side, enabling teams to stay aligned and resolve issues faster.
4. Verify: Track every claim back to its source with sentence-level tracing and automated data verification. Users can click on any sentence to view the exact source file and relevant keywords, ensuring full traceability and confidence in data integrity.
5. Publish: Track progress and package outputs using section status tracking, built-in eCTD support, version history and restore functionality, and DOCX export.

Core Platform Capabilities

• Data Integration: Smart extraction automatically pulls key data points from hundreds of source files, organizing what matters without manual searching through study reports.
• Draft Generation: AI-powered automation generates structured tables, inserts figures, and writes text, allowing teams to focus on the science rather than formatting.
• Content Refinement: Precision editing tools enable fine-tuning of tone, arguments, and content to accurately represent the therapeutic story.
• Streamlined Review: Built-in approval workflows with early issue detection keep reviews moving and submissions on track.
• Traceability & Auditability: Every claim, table, and figure connects directly back to its origin, enabling regulatory questions to be answered in seconds rather than days.
• Collaborative Workflows: Multiple team members can edit simultaneously while the platform tracks who changed what, eliminating lost edits and version confusion.
• Dossier Management: A centralized, structured workspace keeps submission documents and supporting content aligned over time, enabling confident updates.

Regulatory Lifecycle Coverage

• Pre-IND: Organize reports, CMC documents, and scientific literature in one place; generate pre-IND briefing packages for health authority meetings; trace every source document from day one.
• IND: Build Module 2 summaries and Module 3 CMC sections faster; verify supporting data; co-create investigator brochures and study reports in real time.
• Phase 1: Adapt quickly to protocol amendments; track every update to clinical study reports (CSRs); update clinical and scientific content for regulatory filings.
• Phase 2: Manage growing complexity of interim reports; reuse approved content such as investigator brochures without redundancy; deliver accurate content for audits and regulatory reviews.
• Phase 3: Handle large submissions including pivotal CSRs from a single workspace; produce integrated safety and efficacy summaries (ISS/ISE); deliver pivotal filings on time at high volume.
• Approval (Coming Soon): Compile complete NDA/BLA submissions from integrated data; respond to FDA questions and information requests quickly; track submission status and regulatory milestones in real time; prepare for Advisory Committee meetings with organized evidence.
• Post-Market (Coming Soon): Update labeling variations and reports; view content changes across product updates and renewals; provide regulators with traceable risk management and safety data.

Integrations

• Veeva Integration: Fully integrated with Veeva, enabling seamless import and export of documents between Weave Bio and Veeva.
• Always Up-to-Date: Resync functionality automatically updates source files to keep content current.
• Content Plan Ready: Exported documents can be classified and tagged to slot directly into existing regulatory workflows.

Security and Compliance

• Cloud Infrastructure: Built on AWS infrastructure with SOC2 certification launching Q1 2026.
• Access Controls: Multi-factor authentication, single sign-on support, and role-based permissions.
• Data Isolation: AI models never train on customer data, backed by Zero Data Retention agreements.
• Encrypted Processing: End-to-end encryption protects every interaction and data exchange.
• Audit Trails: Complete traceability of all AI interactions and data usage, accessible in seconds.
• Deployment: No installation required — the platform runs from any browser with approximately four weeks of onboarding to get teams fully operational.