Drug development is knowledge orchestration

Weave connects source data, documents, and teams in real time, carrying regulatory context forward from authoring to communication.

Expert-led AI

The question isn’t what AI can do. It’s what it should do. Weave assembles the knowledge so your scientists can shape the argument.

Proof in Practice

8

FDA submissions completed

60%

overall timeline compression

50+

drug development programs supported

Trusted by the best

Customer
stories

We don’t have infinite funding or a large team, so anything that reduces time to market directly increases the value of our company.

Connor Barth, Co-founder and CEO Trace Biosciences

The Weave Platform does what it’s supposed to do. It saves a tremendous amount of time and resources.

Senior Regulatory Leader Top 20 Pharma

I did a quick data integrity check, hit regenerate—and it was perfect. It even caught something I missed.

Senior Advisor, Product Development Operations Top 20 Pharma

Other AI platforms change everything. This changed only what I asked — that’s never happened before.

CEO Small Biotech

AI built for the work behind every submission

Empower your team with purpose-built AI tools for the full regulatory lifecycle. From early portfolio planning to dossier authoring and health authority response.

  1. Candidate
  2. Pre-Clinical
  3. Clinical
  4. Market
  5. Post-Market

Candidate – Market

Launching Q4 2026

Program Planner

  • Portfolio intelligence
  • Project management
  • Regulatory planning
  • Submission simulation

Pre-Clinical – Market

Submission Builder

Explore Submission Builder
  • Briefing books
  • Investigator brochures
  • Protocols
  • Annual reports
  • NDAs / BLAs
  • INDs
  • CTAs
  • CSRs
  • Amendments
  • MAAs

Clinical – Market

HAQ Manager

Explore HAQ Manager
  • Question intake
  • Collaboration and tracking
  • Response generation

For biotech, pharma, and CRO teams

Biotech

Build connected regulatory content and maintain continuity as programs and teams scale.

  • Scale from first program to growing pipeline
  • Keep source content and dossier work connected
  • Reduce manual work across authoring and review

Pharma

Orchestrate multi-program workflows with advanced integration and management.

  • Support enterprise permissions and integrations
  • Manage complex work across programs and teams
  • Maintain continuity across documents and jurisdictions

CROs & consultants

Deliver more value to clients with a white-labeled collaborative platform.

  • Move reviews forward faster
  • Keep client work separate and secure
  • Scale delivery across sponsor engagements.

Privacy & Security

The Weave Platform is designed to protect customer data across connected authoring, dossier management, review, and health authority responses.

Enterprise security

Encryption in transit and at rest

SAML-compatible SSO, MFA, and role-based access

Continuous monitoring and controlled access

Responsible AI

Zero data retention with LLM providers

No customer data used to train AI models

Segregated customer environments

Icon - A-lign SOC 2

Protection designed for sensitive data.

Independently assessed security controls.

Explore Security

Frequently asked questions

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