What Weave does

Weave Bio operates an AI-native regulatory automation platform that helps pharmaceutical, biotechnology, and contract research organizations prepare, manage, and submit regulatory dossiers across the drug development lifecycle. Founded in 2022 and headquartered in San Francisco, the company targets regulatory teams handling IND, NDA, BLA, and CTA submissions to the FDA, EMA, and other global health authorities, replacing fragmented, document-heavy manual workflows with an integrated workspace spanning authoring, source-data extraction, review, eCTD assembly, publishing, and post-submission Health Authority Question (HAQ) response management.

The product surface comprises three interconnected modules: the core Weave Platform as the central authoring and dossier workspace, the eCTD Submission Builder for end-to-end submission preparation, and HAQ Manager for post-submission HAQ response. The platform is built on AWS infrastructure using OpenAI GPT-4.1 and text-embedding-3-small under Zero Data Retention agreements, with proprietary orchestration layers that provide AI-driven drafting, semantic search across source files, sentence-level traceability from source data to dossier, anomaly detection for inconsistencies, customizable AutoReview, and bidirectional sync with Veeva Vault. Technical validation includes a published joint study with Takeda reporting approximately 97% reduction in first-drafting time for IND nonclinical written summaries with no critical AI-generated regulatory errors identified in independent QC, and HAQ Manager reporting 100% precision at 99.7% recall on FDA/EMA question files.

The company operates a quote-based SaaS model with multi-year enterprise contracts and does not publicly disclose pricing. Distribution combines direct enterprise field sales from San Francisco with an exclusive CRO design partnership with Parexel (which gains sole CRO rights to Weave's solutions post-launch) and a technology partnership with Syner-G, which embeds Weave inside its 3D Intelligence (3Di) service offering. Weave Bio has raised approximately $43 million across multiple funding rounds, including a $20 million Series A led by USVP in October 2025, and reports an 11–50 employee headcount range. Named customers include Takeda, Argenx, Recursion, Shattuck Labs, Vistagen, Trace Biosciences, Faeth Therapeutics, Parexel, and Syner-G, spanning enterprise pharma, biotech startups, and CROs.

Name

Weave

Legal name

Weave Bio

Website

https://weave.bio

Company type

Private

Founded year

2022

Operating status

Operating

Headcount range

11–50 employees

Short description

Weave Bio provides an AI-native regulatory automation platform that helps pharmaceutical, biotechnology, and CRO companies prepare, manage, and submit IND, NDA, and CTA dossiers to global health authorities with full traceability from source data to submission.

Ownership category

akta.pro rank

Product category

Regulatory Affairs Software

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Regulatory Information Management (RIM) & Submission Publishing Software (HLAGAJAL)

akta.pro secondary industry

Knowledge Management & Scientific Collaboration / Literature Intelligence (HLAGAJAN)

Keywords

• Regulatory affairs software
• AI regulatory submissions
• ECTD submission builder
• IND NDA automation
• Pharma compliance platform

Headquarters

HQ city

San Francisco

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Infrastructure

Revenue model

1. SaaS Platform Licensing: Weave Bio operates as a SaaS platform providing AI-native regulatory automation to pharma, biotech, and CRO companies. The platform is offered through subscription/licensing arrangements, likely tiered by team size or program scope, with organizations licensing access to the platform for regulatory workflow management. No specific pricing tiers are publicly disclosed.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels7 records

Core offering

Weave Bio provides an AI-native regulatory automation SaaS platform that supports the entire regulatory content lifecycle for pharmaceutical and biotech companies—from Pre-IND through NDA and post-market. Its platform combines an AI-powered document editor, a smart Data Room for source data, a Dossier Manager, an eCTD Submission Builder, and an HAQ Manager module to enable drafting, reviewing, publishing, and responding to Health Authority Questions with built-in FDA, EMA, and global regulatory compliance.

Product overview

Weave Bio offers an AI-native regulatory platform comprising three interconnected products: the core Weave Platform as the central workspace for document management, the eCTD Submission Builder module for end-to-end regulatory submission preparation, and the HAQ Manager module for post-submission Health Authority Question response management. The AutoIND feature specifically accelerates IND drafting. All products share a common data backbone connecting source files to dossier content, enabling traceability and content reuse across the regulatory lifecycle from Pre-IND through post-market.

Differentiator

Problem solved

Functional benefit

Brands

• AutoIND: AI-powered platform designed to streamline regulatory document drafting, reviewing, and submitting for IND applications in drug development. Capable of producing first draft in a single day.
• HAQ Manager
• Submission Builder
• eCTD Submission Builder
• Weave

Products and services

• Weave Platform AI-native regulatory platform that supports the entire regulatory content lifecycle from authoring to publishing and response management. Provides a connected workspace with Document Editor, Data Room, and Dossier Manager components for managing complex dossiers across the therapeutic lifecycle. Target users are regulatory affairs, medical writing, and regulatory operations teams at pharma, biotech, and CROs.
• eCTD Submission Builder AI-powered module for drafting, assembling, reviewing, verifying, and publishing eCTD regulatory submissions. Supports Modules 1-5 and enables movement from raw data to submission-ready packages with ~97% time reduction to first draft. Target users are regulatory operations and regulatory submissions teams at pharma, biotech, and CROs.
• HAQ Manager AI-based tool for managing Health Authority Questions during regulatory review. Extracts questions with 100% precision at 99.7% recall, identifies relevant source files, populates metadata, and generates draft responses in minutes. Saves 500-3,500 hours per year per application. Target users are regulatory affairs teams responding to FDA and EMA inquiries.
• AutoIND AI-powered offering specifically designed for IND (Investigational New Drug) submissions. Produces first draft in a single day, reducing the traditional IND submission process from over a year to a day. Target users are biotech companies preparing their first INDs and regulatory affairs teams managing IND-stage programs.
• NDA Workflow AI-native workflow for New Drug Application submissions developed in partnership with Parexel. Supports full NDA submissions with AI for data extraction, content verification, and automated authoring, enabling 60% faster authoring timelines than traditional manual methods. Includes a pre-loaded Baseline NDA template set available in every account. Target users are regulatory affairs and medical writing teams at pharma and biotech companies managing NDA-stage programs.
• Global Submissions Expanded platform support for global regulatory submissions with customizable dossier structures for different health authorities. Includes a preloaded EU Clinical Trial Application (CTA) template built to EMA section hierarchies and custom template builder for additional markets. Target users are regulatory affairs teams coordinating submissions across FDA, EMA, and other global health authorities.

Quantifiable outcome

• ~97% reduction in first-drafting time for IND nonclinical written summaries (from ~100 hours to 2.6–3.7 hours)
• +7 more outcomes

Named customers7 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability8 records

Feature11 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Syner-GcoreTechnology or Integration · 1 October 2025Syner-G partnered with Weave Bio as its technology provider for AI-augmented authoring and knowledge management across the IND-to-NDA lifecycle. Syner-G launched its 3D Intelligence (3Di) enterprise AI transformation service for biopharma, piloted since October 2025, using Weave Bio's platform for regulatory authoring. The service has yielded significant reductions in authoring time without compromising quality.
• ParexelcoreStrategic or Co-development Partner · 30 September 2025Parexel, a global clinical research organization, entered a strategic partnership with Weave Bio in September 2025 to accelerate regulatory submission processes. Parexel serves as Weave's CRO design partner, gaining exclusivity as the only CRO licensed to use Weave's solutions after new product launches. The collaboration leverages Weave's AI technology with Parexel's regulatory expertise to support faster IND and NDA applications. Parexel has demonstrated 50% faster completion of IND applications using Weave's AutoIND platform.
• Strategic Advisory Board (Boehringer Ingelheim, Takeda, Gilead Sciences, Serrado Capital, Stanford University)minorStrategic or Co-development PartnerWeave Bio formed its inaugural Strategic Advisory Board in March 2026, bringing together senior executives from Boehringer Ingelheim, Takeda, Gilead Sciences, Serrado Capital, and Stanford University. The board provides strategic guidance on regulatory science, health authority policy, and AI integration to shape the evolution of Weave's platform and advance responsible AI adoption in life sciences regulatory workflows.

Scale indicators12 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Veeva Systems: Dominant life sciences cloud platform with Veeva Vault RIM, submissions, and quality suite. Weave positions as the AI-native authoring layer that integrates with Veeva, but Veeva's incumbent footprint across pharma R&D makes it the most strategically important peer for distribution and competitive overlap.
• IQVIA: Global CRO and life sciences technology provider with regulatory services and proprietary assets like Linguamatics NLP for biomedical text. Competes with Weave on enterprise pharma regulatory offerings while also providing potential partnership lanes.
• ICON plc: Large global CRO with growing technology-enabled regulatory and submission services. Competes for the same enterprise pharma and biotech procurement budgets and increasingly integrates AI into its regulatory service offerings.

Direct peers

• ArisGlobal: LifeSphere Regulatory and safety suite used by mid-to-large pharma for RIM, IDMP, and submission management. Most direct functional competitor to Weave's eCTD submission and dossier management capabilities, with growing investment in AI authoring features.
• LORENZ Life Sciences: Specialist in regulatory submission publishing (docuBridge, eCTDplus) serving pharma regulatory teams. Directly comparable in the eCTD submission publishing and lifecycle management workflow that Weave's Submission Builder targets.
• Indegene: AI-driven life sciences services and technology firm with regulatory, medical, and commercial offerings; cited in Weave's own data via the 2022 HAQ Manager time-savings survey. Overlaps with Weave in regulatory authoring, content automation, and pharma commercialization AI.
• Yseop: Enterprise NLG platform widely deployed in pharma regulatory and medical writing automation (e.g., at Sanofi). Direct competitor for AI-authored regulatory narratives and structured reporting, the same core capability Weave markets for IND/NDA authoring.
• Saama Technologies: Life sciences AI platform focused on clinical development, data automation, and submission acceleration. Comparable as a domain-specialized AI vendor selling into pharma R&D with similar GTM benchmarks and target buyer.

Others

• Parexel: Global CRO and Weave's exclusive design partner for AI-augmented regulatory services. Functions simultaneously as a customer, channel partner, and indirect competitor for outsourced regulatory writing services that Weave's automation may substitute.

Emerging players

• Cube RM: Niche player in regulatory information management and submission planning acquired by LORENZ; competes in the RIM adjacent space where Weave is expanding. Smaller scale but focused overlap with Weave's autoIND / dossier coordination capabilities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/weave_bio
• LinkedInlinkedin.com/company/weavebio

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds6 records

Investors9 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Weave