The smartest way
to dossier.
From preclinical IND to postmarket, Weave transforms every stage of therapeutic development.
How it works
Upload
Start with your source data and select from customizable templates aligned to your standards or frameworks like ICH and eCTD.
Generate
Create high-quality first drafts in minutes with automated text, tables and figures pulled directly from your data.
Collaborate
Teams refine content, verify details against source data, and work together in one secure workspace with full traceability.
Submit
Deliver accurate, consistent regulatory dossiers ready for submission.
Why write when you
can weave?
Dossiers require thousands of pages with tons of standard text. 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
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
Integrations:
Secure standalone platform with Veeva integration launching in 2026
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