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Regulatory Reimagined

Regulatory submissions are no longer written.

They’re
programmed.
built.
designed.
architected.
woven.
programmed.

Our Customers

Driving regulatory innovation with these leading companies.

A dynamic record of your therapeutic candidate

Harness the power of AI with Weave's regulatory automation management platform, designed to streamline the regulatory submission process. Our AI-native workbench allows you to efficiently refine and structure documents with ease. With just the push of a button, you can create drafts that incorporate your existing content. Need to fill in missing key details? Want a different narrative structure? Looking to adjust the level of detail? Simply ask the AI for assistance. When you’re ready to verify sources for every sentence, access them with one click. Need a table summarizing key studies? Just request it.With Weave, regulatory documentation evolves alongside your program, empowering your team to stay aligned, efficient, and focused on advancing your science.

With Weave, regulatory documentation evolves alongside your program, empowering your team to stay aligned, efficient, and focused on advancing your science.

From six months to six clicks with Weave's regulatory automation management platform

Plan and organize, then draft with one click

Iterate rapidly to get to submission-ready content

Validate data accuracy to reinforce confidence

Try Weave Today

Weave together millions of source threads at the speed of AI and cut your IND application time.

The new standard in regulatory automation and lifecycle management

The Weave Platform is AI-powered regulatory submission software that streamlines regulatory workflows, ensuring submissions are structured, consistent, and aligned with FDA and global standards. Built around the eCTD (electronic Common Technical Document)—the FDA’s standardized format for regulatory submissions—Weave intelligently organizes data, drafts submission-ready content, and provides real-time document validation.

With its adaptive AI framework and structured templates, Weave rapidly adjusts 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 consistently high-quality content.

Don’t just assemble data, tell the story of your drug.

Accelerate Drafting
Efficiently Navigate Data
Streamline QC & Review

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

Regulatory has one home

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