The smartest way
to dossier
From preclinical IND to postmarket, Weave transforms every stage of therapeutic development. Our eCTD-formatted templates deliver powerful regulatory workflow automation while keeping you confidently in control of every submission.
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
Just launched
Introducing HAQ Manager
Post-submission review is now a whole lot easier
HAQs are make-or-break in drug development.
Questions come fast, sometimes hundreds at once—with answers expected in as little as 24 hours. With Weave’s HAQ manager, responses that normally take days or weeks are generated in minutes—with unmatched accuracy.
Built and tested with direct input from a top-20 pharma company, Weave extracts questions at 93% precision and 95% recall when tested across sample question files from the FDA and EMA.
How it works
Your HAQ Manager automatically extracts individual questions, finds relevant source files from your Data Room and categorizes metadata—eliminating manual errors. While HQ handles the heavy lifting, you stay in control. Need to add questions or guide new responses? Simply assign or override field values anytime to get the results you need—fast.
01
Meet impossible deadlines
Handle unstructured requests in minutes instead of weeks
Weave produces responses of every kind—narrative, tabulated or other structured content—directly in your 1.11 section.
02
Collaborate across functions
Unite regulatory, clinical, CMC and nonclinical teams in one shared workspace
Assign the right SMEs to author and review each question, collaborating with colleagues and leveraging AI for ready-to-submit responses.
03
Link with
confidence
Trace every answer to its verified source
Use the expanded preview to compare details side by side with the original, including any related questions, to ensure every response is backed by trusted 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
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
Integrations
Fully integrated with Veeva
Syncs with your source data
01
Syncs with your source data
Draft 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