Global Submissions From a Single Source of Truth

Weave Bio has expanded its platform to support global regulatory submissions from one connected source of truth. Teams can now structure filings for different health authorities while working from the same underlying program data. New dossier customization capabilities include a preloaded EU Clinical Trial Application (CTA) template.

Regulatory teams often rebuild dossiers when they prepare submissions for new jurisdictions. Weave reduces that repeated work by connecting source data across a program. Teams can draw from one verified reference set across filings and reuse previous submissions as the foundation for future regulatory activities.

What this means for regulatory teams

Drug development programs are global, but submission structures vary by jurisdiction. Weave supports those differences with customizable dossier structures. Teams can configure sections, folders, and document organization to match the requirements of different health authorities.

The platform includes a preloaded EU CTA template built to European Medicines Agency (EMA) section hierarchies. Teams can also use a custom template builder to create structures for additional markets. Weave plans to introduce more partner-developed templates for other jurisdictions in future releases.

Looking ahead

These new capabilities expand Weave’s support across the regulatory lifecycle, from INDs and CTAs to NDAs and beyond. As organizations pursue global development strategies, they can manage submissions across markets without rebuilding dossiers for every new filing.

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The Weave Bio NDA Workflow extends the platform’s capabilities to support New Drug Application submissions. Developed in partnership with Parexel, this expansion reflects how teams are applying AI across the full regulatory lifecycle.

Preparing an NDA requires bringing together years of clinical, non-clinical, and manufacturing data under tight timelines and high expectations. Historically, this has meant months of manual work. With the introduction of NDA workflows, Weave continues building a human-driven, AI-enabled platform designed to support teams through these critical moments.

The launch of NDA support reflects a broader shift in how regulatory teams approach document development. As programs grow in complexity, teams need systems that connect data, decisions, and content across the lifecycle—ensuring alignment as information evolves.

By working closely with Parexel, Weave developed NDA capabilities shaped by real-world submission experience. This collaboration brings together regulatory expertise and AI development to support accuracy, consistency, and scale in NDA authoring.

What this means for regulatory teams

NDA submissions represent one of the most complex and high-stakes phases in drug development. As a result, teams must manage large volumes of data while maintaining clarity, traceability, and alignment across contributors.

With NDA workflows now available, the Weave platform supports how teams structure, author, and verify content at scale. By connecting underlying data with document development, teams can reduce manual effort while maintaining control over narrative and quality.

In addition, the platform reflects how regulatory work happens in practice—supporting collaboration across functions and adapting as programs evolve. As teams move from early development through submission, maintaining continuity across data, context, and content becomes increasingly important.

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Looking ahead

Looking ahead, Weave will continue expanding platform coverage across the regulatory lifecycle, building on the foundation established with NDA workflows. As regulatory demands increase, supporting teams through high-stakes milestones with connected systems will remain a priority.

At the same time, Weave will continue developing AI capabilities grounded in how regulatory teams actually work—ensuring that data, decisions, and content remain aligned as programs evolve. Partnerships like the one with Parexel will play a key role in shaping how the platform grows, with input rooted in real-world submission experience.

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The Weave Bio Strategic Advisory Board brings together leaders across pharma, academia, and capital markets. This group helps guide the responsible use of AI in regulatory science. It also marks an important step as Weave continues building a human-driven, AI-enabled platform across the therapeutic lifecycle.

The formation of the Weave Bio Strategic Advisory Board reflects a broader shift in how teams apply AI in regulatory science. As expectations evolve, organizations must combine deep regulatory expertise with AI development. This ensures accuracy, trust, and scientific rigor.

By bringing together leaders from across the ecosystem, Weave builds with direct input from experts shaping regulatory strategy, policy, and innovation today.

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What this means for regulatory science

Today, AI plays a growing role in regulatory science. As a result, organizations must ensure these systems align with regulatory expectations, scientific standards, and real-world workflows.

In addition, the advisory board connects industry practice with product development. Its members bring firsthand experience working with health authorities and leading innovation in global pharma organizations. This helps ensure the Weave platform reflects how regulatory work happens today while supporting where the field is going.

As the platform evolves, the board will help guide how teams apply AI across the regulatory lifecycle—from early development through clinical and post-market activities. Throughout this process, accuracy, transparency, and trust remain central.

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Looking ahead

Looking ahead, the Weave Bio Strategic Advisory Board will continue to support the platform’s expansion across the regulatory lifecycle. As AI reshapes regulatory work, maintaining alignment with industry expectations will remain critical.

At the same time, Weave will continue building technology that reflects how regulatory teams operate today. The board’s insights will help ensure that AI development stays grounded in practical application and real-world impact.

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The Weave Bio HAQ Manager extends the platform’s capabilities into the Health Authority Questions phase—supporting teams as they navigate one of the most time-sensitive and detail-oriented parts of the regulatory process. This launch reflects how regulatory teams are applying AI not just in document creation, but in managing ongoing dialogue with health authorities.

Responding to HAQs requires rapid coordination across teams, with each response grounded in existing submission content, supporting data, and prior decisions. Historically, this process has relied heavily on manual tracking, fragmented communication, and repeated rework under tight timelines. With HAQ Manager, Weave continues building a human-driven, AI-enabled platform designed to support teams in these high-pressure moments.

The introduction of HAQ Manager reflects a broader shift in how regulatory teams approach post-submission work. As programs advance, maintaining alignment between submitted content and ongoing responses becomes increasingly complex. Teams need systems that connect questions, answers, source data, and prior context—ensuring consistency as information evolves.

Built to reflect real-world regulatory workflows, HAQ Manager supports how teams triage, draft, review, and finalize responses. By connecting each question back to source documents and structured data, the platform helps maintain traceability while reducing time spent searching for information.

What this means for regulatory teams

Health Authority Questions introduce a new level of urgency and coordination following submission. Teams must quickly interpret questions, identify the right subject matter experts, and develop accurate, aligned responses—often across multiple functions and time zones.

With HAQ Manager, the Weave platform supports how teams organize and respond to these requests at scale. By linking questions to underlying data and prior submissions, teams can reduce manual effort while maintaining control over response quality and consistency.

In addition, the platform reflects how regulatory work continues beyond submission—supporting collaboration, iteration, and alignment as new information emerges. Maintaining continuity between original submissions and HAQ responses becomes critical in ensuring clarity and confidence in every interaction.

Looking ahead

Weave will continue expanding platform coverage across the regulatory lifecycle, building on the foundation established with HAQ Manager. As regulatory interactions become more dynamic, supporting teams through both submission and review phases with connected systems will remain a priority.

At the same time, Weave will continue developing AI capabilities grounded in how regulatory teams actually work—ensuring that data, decisions, and content remain aligned from submission through review.

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Weave Bio AI is proud to announce that it has received the BioTech AI Innovation Of The Year award in the fourth annual BioTech Breakthrough Awards program conducted by BioTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout life sciences and biotechnology companies, products, and services around the globe.

The acknowledgement validates the significance of Weave’s commitment to provide technically robust, AI-enabled solutions that move candidates through regulatory approvals and clinical trials, and out to market faster.

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Weave Bio has secured $10 million in funding to accelerate its mission of streamlining regulatory processes for pharma and biotech. Its AI-powered platform, starting with AutoIND, automates and accelerates the IND submission process, reducing preparation time by over 50% and potentially bringing new therapies to patients faster while lowering development costs.

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