Meet your Submission Builder
Weave Bio Submission Builder supports regulatory teams as they prepare, organize, and manage eCTD submission content across the regulatory lifecycle.
Move from raw data to submission-ready packages faster with an end-to-end AI platform for drafting, assembling, reviewing, verifying, and publishing regulatory submissions.
How It Works
Step 1: Draft & iterate
Customize and populate AI templates with variables, maintaining context as you iterate, so teams can refine and improve work over time without losing the thread. Generate and refine content for Modules 1 (including IB), 2, 3, and 5.
Step 2: Assemble
Automate submission formatting and table/figure handling, keeping citations and cross-references current, including intra-document, inter-document, and literature references.
Step 3: Review
Collaborate live in a shared workspace where comments, context, and redline suggestions stay side-by-side, so teams stay aligned and resolve faster.
Step 4: Verify
Track every claim back to its source with sentence-level tracing and automated data verification..
Step 5: Publish
Track progress and package outputs with section status tracking, built-in eCTD, version history/restore, and DOCX export.
Why write when you
can weave?
Dossiers are comprised of thousands of pages of complex, technical content specific to your therapeutic. Weave generates those in minutes, so you can show people how your newest therapy will change the world.
Preclinical to postmarket
One platform. Every milestone.
Pre-IND
- Organize reports, CMC docs 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 the data supporting your IND submission.
- Co-create investigator brochures and study reports in real-time
Phase 1
- Adapt to protocol amendments fast
- Track every update to your CSRs
- Update clinical and scientific content for regulatory filings
Phase 2
- Handle the growing complexity of interim reports and updates
- Reuse approved content like investigator brochures without redundancy
- Deliver accurate content for audits and regulatory reviews
Phase 3
- Handle large submissions like pivotal CSRs from one workspace.
- Produce polished integrated safety and efficacy summaries (ISS/ISE).
- Deliver pivotal filings on time, even 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 without the hassle
- View content changes across product updates and renewals
- Give regulators traceable risk management and safety data
Purpose-built for regulatory
Takeda study finds Weave increases efficiency in regulatory writing
Regulatory AI should work reliably. That’s why we partnered with Takeda to ensure Weave supports your regulatory work with the precision you expect at astonishing speed.
- Turns ~100 hours of IND nonclinical written summaries into as little as 2.6-3.7 hours
- Independent QC assessment found no critical AI-generated regulatory errors
- Clarity and concision are opportunities for refinement—showing how important expert human reviews are to the process
Integrations
Fully integrated with Veeva
Syncs your documents
01
Syncs with your source documents
Import and export between Weave and Veeva with ease.
02
Always up-to-date
Resync to automatically update your source files.
03
Ready for your content plan
Classify and tag your exported docs to slot right into your workflows
Data security & AI privacy
Security and compliance you can count on
Built with AWS infrastructure, zero data retention and enterprise security controls.
Platform security
architecture
Cloud security:
Built on AWS infrastructure with SOC2 certification launching Q1 2026
Access controls:
Multi-factor authentication, single sign-on support, and role-based permissions
Platform requirements:
No installation headaches—just 4 weeks of onboarding to get up and running from any browser
Secure AI
processing
Data isolation:
AI models never train on your data with 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 in seconds