Fully customizable dossier structures, including a preloaded EU Clinical Trial Application template, extend platform coverage to any health authority worldwide.
SAN FRANCISCO–(BUSINESS WIRE)–$TMV #AI–Weave Bio, the leader in AI-native regulatory automation for drug development, today announced new global submission capabilities that give drug development teams one connected platform for every regulatory filing across a program’s lifecycle, from an Investigational New Drug (IND) application and Clinical Trial Application (CTA) to a New Drug Application (NDA) and beyond. Available immediately, the enhancements establish a single source of truth across jurisdictions, with AI accelerating every step from data extraction to submission.
Regulatory submissions have traditionally required teams to rebuild dossiers from scratch for each new jurisdiction. The Weave platform eliminates that pattern, connecting source data across the full arc of a program so teams can draw on one verified reference set for every subsequent filing. In this way, each submission is created from the same source data, and becomes a reusable playbook for the next.
“Drug development programs are global, and the science doesn’t change when you cross a border. The submission structure does. Weave follows every therapy wherever it needs to go, across any jurisdiction, all the way to approval,” said Brandon Rice, CEO and co-founder of Weave Bio.
The expansion includes a pre-loaded EU CTA template, built to European Medicines Agency (EMA)-compliant section hierarchies. For teams targeting additional markets, a custom template builder allows for full configuration of sections, folders, and document structures to match any health authority’s requirements. This initial release by Weave is available immediately, with more partner-developed templates across additional jurisdictions to follow.
The announcement comes ahead of the DIA 2026 Annual Meeting in Philadelphia, where Weave Bio will present in two sessions. Regulatory teams working on EU filings or planning international expansion can visit booth 1218 for a live demonstration.
About Weave Bio
Weave Bio is an AI-native software company transforming how novel therapies navigate the complex path from lab to market. The Weave platform streamlines regulatory content preparation and lifecycle management for pharmaceutical companies, biotech firms, CROs, and regulatory consultants by infusing AI into every step of the workflow, from data extraction and authoring to review and verification, yielding compliant, submission-ready regulatory dossiers with unprecedented speed.
Founded in 2022 and headquartered in San Francisco, Weave is backed by leading investors including USVP, Innovation Endeavors, Magnetic Ventures, Character, TMV, and Serrado Capital, and trusted by innovative biopharma companies worldwide.
For more information, visit weave.bio and follow us on LinkedIn.
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Weave Bio
Tammy Lyons
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