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AutoIND

Our flagship product, AutoIND, is a powerful, flexible, cloud-based AI-native regulatory automation management solution designed specifically for Investigational New Drug (IND) preparation.

By streamlining the drafting process, AutoIND can reduce preparation time by up to 70%, significantly increasing your team’s capacity to manage submissions while lowering operational costs. Leveraging advanced AI capabilities, AutoIND enhances regulatory workflows, ensuring compliance and accelerating time-to-market for critical therapies.

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Plan and organize files effortlessly

Utilize templates to structure your dossier. Upload source files and summarize instantly. Rely on the built-in eCTD structure for auto classification. Continuously track progress with gap analysis.

Draft content in minutes

Generate first-draft content at the push of a button. Leverage AI for refinement, automatic table creation, and seamless updates with AutoUpdate. Easily accept, reject, or edit suggestions to iterate rapidly and efficiently.

Verify data to reinforce confidence

Assign AI reviewers, track edits with version history, and roll back to previous versions as needed. Automatically flag inconsistencies and verify data by tracing content to its sources in just two clicks.

Regulatory has one home

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