Submission Builder
Lean content authoring across
the drug development
lifecycle
Weave Bio Submission Builder supports regulatory teams as they prepare, organize, and manage eCTD submission content across the regulatory lifecycle.
Author connected content across the dossier, from investigator’s brochures, protocols, and clinical study reports through IND, NDA, and BLA development. AI-assisted drafting, review, verification, and source traceability keep the work connected as the dossier evolves.
Proof in practice
8
FDA submissions supported
60%
faster submission timeline
97%
faster to first draft
How it works
Author & iterate
Create and refine content with configurable AI templates grounded in source context, not disconnected prompts.
Assemble dossier
Organize content within the appropriate eCTD structure while keeping tables, citations, and cross-references connected.
Review together
Collaborate in a shared workspace where comments, context, and redlines stay together, helping teams address feedback faster.
Verify sources
Track every claim back to its source with sentence-level tracing and automated data verification for added confidence.
Export content
Prepare finalized content for publishing with section status, version control, restore, and DOCX export.
More than another AI writing tool
Submission Builder is built around the structure, evidence, and continuity required across complex drug development programs.
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
Data Security & AI Privacy
Built for sensitive drug development data
Designed to protect your source data and draft content at every step of building a submission.
Built into your workflow
Role-base permission
Control who can author, edit, and approve content within a dossier, with access managed by role.
Full audit trail
Every edit, comment, and version is logged, giving reviewers complete visibility for compliance review.
Version control
Changes are tracked as multiple people work in the same submission, so nothing is lost or overwritten.
Secure AI
Zero data retention
Customer data is not stored by OpenAI.
No model training
Neither Weave nor its vendors use customer data to train, retrain, or improve AI models at any stage.
Data isolation
Customer data remains segregated within its own environment, with access controlled on a need-to-know basis.
Protection designed for sensitive data.
Independently assessed security controls.
Integrations
Connect to the systems your teams already use
Bring source documents into Weave and move completed content back into established systems, including Veeva.
01
Connect source content
Bring source documents into Weave from connected repositories while preserving their folder structure.
02
Keep files current
Resync source files as they change so teams can work from the latest available content.
03
Export final content
Export and classify completed documents for use in established content workflows.
Frequently asked questions
Need to manage health authority questions after submission?
Connect incoming questions to source knowledge, prior responses, and related dossier content with HAQ Manager.