Compliance & Validation — Not documented by Atlas
Ask the vendor: Which compliance certifications (HIPAA, 21 CFR Part 11, SOC 2, GxP) do you hold?
Weave Bio
AI-native regulatory automation platform whose AutoIND module drafts Investigational New Drug application sections.
Weave Bio, founded in 2022 and headquartered in San Francisco, California, builds an AI-native regulatory automation platform for life sciences; its AutoIND module ingests a sponsor's own data, public information, and regulatory guidance to draft Investigational New Drug (IND) application sections for human review, with a roadmap extending toward NDA, BLA, and health-authority question/response workflows. The company reports roughly $30M raised across a 2024 seed round and a 2025 Series A led by USVP. Atlas found no vendor-held security certifications documented on its site; drafts are AI-generated and require regulatory-team review before submission.
- Headquarters
- San Francisco, United States
- Founded
- 2022
- Deployment options
- cloud
- Website
- https://weave.bio
- https://www.linkedin.com/company/weavebio
Categories
AI Use Cases
- Regulatory Submission Authoring
Vendor Scorecard
57% — Partial coverage. Coverage score — how completely Atlas documents Weave Bio across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud
Pricing Transparency — Not documented by Atlas
Ask the vendor: What is your pricing model, and what drives total cost of ownership?
Implementation & Onboarding — Not documented by Atlas
Ask the vendor: What is a realistic implementation timeline, and what onboarding support is included?
Organization & Role Fit — Documented
Biotech Startup, Mid-Size Biotech, Large Pharma, Top 20 Pharma, Regulatory Affairs, Medical Affairs
Solution Scope — Documented
Natural Language Processing, Regulatory Submission Authoring
Company Viability — Documented
Series A, $30.0M raised, Founded 2022
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Questions to Ask This Vendor
- Which submission types are supported in production today beyond IND?
- How does the human review and sign-off workflow document accountability?
- How is our proprietary clinical and CMC data protected during generation?
- What security and compliance documentation can be provided during evaluation?