Regulatory Reimagined
Regulatory submissions are no longer written.
The new standard in regulatory automation and lifecycle management
The Weave Platform is the only AI-powered, regulatory automation management platform for the entire lifecycle of a therapeutic candidate. Weave's cloud-based software streamlines regulatory workflows, ensuring content is accurate, structured, consistent, and aligned with FDA and global standards. Built around the eCTD (electronic Common Technical Document) structure—the FDA’s standardized format for regulatory submissions—Weave intelligently leverages AI templates, organizes data, automatically drafts, and offers tool to rapidly develop, iterate on and validate submission-ready content.
With its adaptive AI framework and customizable AI templates, Weave's platform can effortlessly manage source data and adjust generated content to meet global regulatory requirements, including those in Europe and Canada. Your team gains a single AI-powered source of truth for the life of your therapeutic candidate, enabling seamless collaboration, faster submission timelines, and high-quality, connected content through all phases of the lifecycle.
End-to-end regulatory automation
Harness the power of AI with Weave's flexible platform, designed to streamline the entire regulatory process. The Weave Platform offers a robust data room and AI workbench to draft, refine and structure documents with ease.
At the push of a button, you can create and format content that summarizes extensive, evolving source material. Want a different narrative structure? Looking to adjust the level of detail? Need a table summarizing key studies? Simply ask the AI for assistance. Then when you’re ready to verify sources for every sentence, you can access your source files with just one click.
With Weave, regulatory documentation evolves alongside your unique programs, empowering your team to stay aligned, efficient, and focused on advancing your science. It's the only trusted platform that supports the dynamic regulatory process for all therapeutic candidates in your pipeline
Plan and organize, then draft with one click
upload
Import source files and summarize instantly
draft
Utilize in platform templates and push button first drafts
Iterate rapidly to get to submission-ready content
REFINE
Optimize content instantly by instructing the AI
Review
Collaborate seamlessly on reviews and add in our AI reviewer
Validate data accuracy to reinforce confidence
verify
Confirm accuracy with two-click tracing from content to sources
publish
Publish from a single platform when content is ready
From six months to six clicks with Weave's regulatory automation management platform
Our Customers
Driving regulatory innovation with these leading companies.
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Try Weave Today
Weave together millions of source threads at the speed of AI and cut your IND application time.
Don’t just assemble data, tell the story of your drug.
Accelerate Your Document Drafting
- Auto generate drafts within minutes
- Ensure adherence to regulatory guidelines
- Refine content with AI augmentation
- Maintain complete editing control
- Focus on more meaningful creative and strategic questions
Efficiently Navigate Your Data & Source Files
- Organize content effortlessly
- Tag and search document categories
- Automatically generate summaries
- Trace content to source documents rapidly
- Feel more confident and in control of the process
Streamline Your QC & Review Process
- Auto update quickly with new reports
- Easily resolve IND data conflicts
- Generate reports on affected sections post-update
- Collaborate effectively with multiple reviewers
- Worry less about errors and inconsistencies
