HomeProductResourcesInsightsCompliance & Security About
Insights

Announcement

Indago Launches the First Claude Connector Built for Regulatory Drafting

IRDA puts Indago's drafting engine inside Claude. Upload or connect your study reports, ask questions, find the gaps and draft submission sections with a source behind every sentence. Free to get started today.

Indago, Inc. today launched the Indago Regulatory Drafting Agent (IRDA), the first connector in Claude's directory built to draft regulatory submissions. Regulatory professionals can install it in minutes, upload or connect their own study reports and CMC documents, and ask questions, run a gap analysis or draft submission sections inside Claude, with every answer tied to the document it came from.

IRDA is available today in the Claude directory. It is free to try, with paid plans from $99 a month.

"Regulatory professionals should be able to get a first draft they can defend, with a source behind every sentence, without a procurement process or a consulting bill. We built the first Claude connector that drafts regulatory submissions so anyone can do that on their own documents today."

Kolton Tebbey, Founder, Indago

Regulatory drafting needs the evidence attached

A submission restates the same facts dozens of times. A NOAEL from one tox study appears in the nonclinical summary, the overview, the dose rationale and the Investigator's Brochure, and every instance has to match the study report behind it. Getting there means reading hundreds of pages from several CROs and keeping every number consistent by hand.

General AI tools can speed up the writing, but they can't show where a statement came from, and on a document the size of an IND they lose track of the facts. Every line still has to be checked against the source. IRDA drafts from the program's own documents and returns each claim with its source, so checking a draft takes a click.

What IRDA does

  • Ask your documents. Questions across the whole corpus come back with the document and section behind each answer. When the documents don't support an answer, IRDA says so.
  • Run a gap analysis. Check a program against its target submission and get a ranked list of findings, each naming the CTD section, what is missing and where IRDA expected to find it.
  • Draft a section. Generate a first draft of any Module 2, Pre-IND or NDA/BLA section from the program's source documents, returned with the sources it drew on.
  • Redraft against feedback. Revise a section with written comments and see exactly what changed.
  • Verify a draft. Every draft carries an ID. Paste it back to confirm the text still matches what Indago produced.

How it works

Claude handles the conversation. Indago processes the program's documents into a private workspace, drafts on its own engine against that corpus, and returns finished text with its sources named. Drafts come from the program's evidence and never from general knowledge.

  1. Your documentsUpload files through Indago, or connect SharePoint, OneDrive or Google Drive.
  2. Your Indago workspaceProcessed privately. Drafting runs on Indago's engine against your own corpus.
  3. ClaudeAsk, run a gap analysis or draft a section. Every answer comes back with its source.
Source files never pass through the chat. Model providers retain no customer data and never train on it.
  1. Install IRDA from the Claude directory.
  2. Sign in once and accept the terms on a single page. Your private workspace is created on submit.
  3. Upload your files through Indago's upload interface, or connect a SharePoint site, OneDrive or Google Drive folder.
  4. Ask a question, run a gap analysis or draft your first section.

Your documents stay in Indago

Source files never pass through the chat. They are processed in a private Indago workspace, and the drafting runs on Indago's engine. The scope of a connected folder is fixed when it is authorized and can be revoked at any time. The model providers Indago uses retain no customer data and never train on it.

Pricing

PlanPriceIncludes
Free trial$0One section draft, three AI reworks and one gap analysis, to try it on your own program.
Standard$99 a monthTwo new section drafts, ten reworks and two gap analyses a month.
Pro$299 a monthFour new section drafts, thirty reworks and five gap analyses a month.

Editing a draft by hand is always free. Plans are purchased inside the connector.

Frequently asked questions

Which sections can IRDA draft?

Any Module 2, Pre-IND or NDA/BLA section, drafted from your program's own documents.

Does my data train anyone's model?

No. The model providers Indago uses retain no customer data and never train on it.

What happens to my documents if I stop paying?

Your corpus and drafts are removed 90 days after a plan lapses. While a plan is active, a drafted section stays drafted.

Can my team use it together?

IRDA is single-seat. For team plans with shared review and collaboration, reach us at sales@indago.bio.

Get IRDA

Install IRDA from the Claude directory at claude.ai/directory/indago-bio. Setup guides are at docs.indago.bio, and a walkthrough of the full platform is at indago.bio/resources.

Install IRDA Read the setup guide

About Indago

Indago, Inc. builds regulatory drafting software for biotech teams preparing Pre-IND, IND and NDA/BLA submissions. Every statement it drafts links back to its source document, so regulatory professionals can check a claim in one click. Learn more at indago.bio or write to sales@indago.bio.

Ready to see it on your own studies?

Thirty minutes, no prep. Bring a study report and we'll walk it through to a cited, defensible draft.