Draft IND submission documents inside Claude.
IRDA (Indago Regulatory Drafting Agent) puts Indago's regulatory drafting engine inside Claude. Point it at your study reports, protocols, CMC data and prior submissions. It drafts CTD Module 2 sections from your own source files, and every claim traces back to the document and page it came from.
What IRDA is
IRDA is a remote connector for Claude. When you connect it, Claude gains a set of tools that talk to your Indago workspace: list your programs and documents, search the evidence Indago extracted, read tables cell for cell, draft and edit CTD sections, and correct the engine's classifications. Your source documents stay in Indago. Claude sees what the tools return: excerpts, citations, tables, drafts and answers.
It drafts CTD Module 2 sections (2.2 Introduction, 2.4 Nonclinical Overview, 2.5 Clinical Overview, 2.6 and 2.7 Summaries) in the structure reviewers expect, and hands back a working draft you can edit. It is built for regulatory affairs teams at IND-stage biotechs, and the consultants and CROs who file on their behalf.
A regulatory professional stays in the loop. IRDA produces working drafts for review, edit and approval. It does not file anything on your behalf, and a drafted section is not a submission.
Connect Claude to Indago
claude.ai and Claude Desktop
- Open Settings → Connectors and choose Add custom connector (once IRDA is listed in the connector directory, choose it there instead).
- Enter the server URL
https://mcp.indago.bio/mcpand confirm. - Click Connect. A browser window opens on Indago's sign-in page. Sign in with your work email. If you do not have an Indago account yet, create one: a private workspace is created for you during sign-in.
- Back in Claude, start a chat and enable the Indago connector for that chat. Ask "What programs do I have in Indago?" to confirm it works.
Claude Code
claude mcp add --transport http indago https://mcp.indago.bio/mcpThen run /mcp, pick indago and choose Authenticate. Any client that supports remote MCP servers with OAuth can connect the same way.
Sign-in uses OAuth. Claude never sees your Indago password, and Indago never sees your Claude conversation. You can disconnect at any time from the same Connectors page.
Quick start
- Create a program. "Create a program called NVT-317 in Indago." A program is one product's workspace: its source corpus, evidence and drafts.
- Add your documents. "How do I add my study reports?" Claude returns a secure upload link to the program's Sources page in the Indago app. Drag your PDFs and Word files there. Files upload straight to Indago and never pass through the chat.
- Wait for processing. "Is it done processing?" Indago parses each document, extracts tables and figures, reads every passage and builds a corpus map of studies, documents and sections. Claude can wait with live progress or check back later.
- Ask a question. "What did the 13-week study find about body weight?" The answer cites document, page and table, and says what was examined.
- Draft a section. "Which sections can Indago draft? Draft 2.6.6.3." The finished draft arrives in the chat with per-sentence citations and the engine's own flags for thin or missing evidence.
- Review, edit, correct. Read the draft as the signing reviewer. Ask Claude to replace, insert or delete sentences, add evidence the extractor missed, or fix a mis-filed document. Every edit becomes a new version.
- Finish in the app. Open the program at app.indago.bio for the notebook editor, version history, source viewer, gap analysis and export.
Add your source documents
Indago reads PDF and Word documents: study reports, protocols, investigator brochures, CMC documentation, prior summaries and working drafts. Two routes exist.
- Secure upload link. Ask Claude for an upload link. It deep-links to the program's Sources page in the Indago app, where you are already signed in. This is the route for confidential material.
- Public URL. For documents already at a public address, such as published literature or agency guidance, Claude can add the URL directly and Indago fetches it.
Each document shows a processing status (processing, completed, error) and, when complete, a count of the claims extracted from it. If a document errors, the error text is shown so you can tell whether the file is the problem.
Do not upload protected health information, personal data beyond business contacts, payment data or export-controlled material. See the Acceptable Use Policy.
Ask questions with citations
Asking is grounded retrieval, not free recall. Indago routes the question using the corpus map (it recognises study and document names), searches passages and extracted tables, and answers from what it found. Every answer carries citations with document, page, section and table identifier, plus a short trace of what was examined. When the corpus does not support an answer, Indago says so rather than guessing.
- Narrow a question to one study or document: "In the Labcorp 8497426 report, what was the dose regimen?"
- Quantitative questions open the relevant table. Multi-page tables are read as a family; fragments and flagged rows are disclosed rather than silently merged.
- Ask for the page image when you want to check a value yourself: "Show me page 47 of that report."
Draft a section
Start with "Which sections can Indago draft?" Indago lists the CTD sections that have enough evidence in the corpus. Then ask for one. Drafting runs on Indago's engine and can take several minutes for a long section; Claude shows progress and returns the finished draft. If the call is interrupted, ask Claude to read the section again and it resumes from the stored draft.
A draft contains:
- The section text, sentence by sentence, each with the claim identifiers it rests on and their document and page.
- Flags where the engine's evidence was thin, or where a statement needs a reviewer's eye.
- For table sections such as batch analyses or stability, the generated table itself, derived from the source tables.
Drafts are working drafts. They are written from your sources, not templates, and are meant to be read critically by the person who will sign the section.
Review and edit a draft
You can edit a draft from the chat. Ask Claude to replace, insert or delete sentences, or to attach evidence to a sentence that lacks it. Two rules apply:
- Authored text cites. Any sentence you or Claude writes into a draft must name the claim identifiers it rests on. Claude finds those with the evidence tools, or creates them from a page you point to.
- Edits make versions. Every edit is stored as a new version with the author and a note. Nothing is overwritten. Version history is in the Indago app.
For larger changes, ask Claude to refine the section with instructions and pinned evidence, for example "Rework the mortality paragraph to lead with the Day 4 findings and cite Table 3." Refining re-runs the engine on that section and produces a new version. Manual editing is always free and unmetered.
Correct what Indago got wrong
Extraction is imperfect and the corpus map is the engine's best reading of your documents. Anything you could change in the Indago app, you can change from Claude, and every change is logged with your identity and note.
| What is wrong | What to ask |
|---|---|
| A document is filed under the wrong CTD section, attached to the wrong study, or misnamed | "Move the tolerability report to 2.6.6.2 and attach it to study 3106." |
| A study's metadata is wrong (species, route, regimen, GLP status, duration) | "That study was IV, not oral. Fix it." |
| The document card's judgment is wrong (for example study type, or which section it fits) | "This is a repeat-dose study; it belongs in 2.6.6.3." |
| A claim is mis-tagged, mis-typed, badly worded, or should not exist | "Retag that claim as pharmacokinetics." · "Delete the legend row that was extracted as a finding." |
| The extractor missed a fact you can see on a page | "Add a claim from page 12: the NOAEL was 30 mg/kg." Claude must name the document and page. |
| A table was parsed wrong (split across pages, a missing column, a header read as data) | "Stitch the two fragments of Table 5 and mark it reviewed." |
Ask "What vocabularies can I use?" to see the controlled values for claim types, card fields, study fields and table kinds before making a correction.
Working in the Indago app
The connector and the app are one workspace. Everything you do in Claude is visible in the app, and the reverse. Use the app at app.indago.bio for uploading confidential files, the notebook editor with live provenance, side-by-side source viewing, version history, gap analysis against the target submission type, and export. Submission assembly, the consistency pass, the full provenance record and compiled export are platform features.
Tool reference
Claude chooses tools from your request; you do not need to name them. This list is for understanding what the connector can and cannot do. read tools change nothing. write tools create or change data in your workspace and are logged. destructive tools remove data.
| Tool | What it does | |
|---|---|---|
list_programs | Programs in your workspace | read |
get_usage | Your plan and remaining allowance; free to call | read |
create_program | Create a new program workspace | write |
get_upload_link | Secure link to the program's Sources page for uploading your files | read |
add_source_from_url | Ingest a document from a public URL | write |
list_documents | Source documents and processing status | read |
wait_for_processing | Wait, with progress, until processing finishes | read |
get_program_overview | The corpus map: studies, documents, sections, counts | read |
get_document_card · get_study_card | The engine's judgment about one document or study | read |
get_document_outline · get_document_items | A document's heading structure and its parsed items | read |
get_page_image | Rendered image of one source page | read |
ask_indago | Grounded, cited question answering over the corpus | read |
search_evidence | Full-text and semantic search over passages, tables and figures | read |
get_source_tables · get_table | List extracted tables; read one cell for cell, including multi-page families | read |
get_source_figures · get_figure | List extracted figures; read one figure's card | read |
get_section_evidence | The claims behind one CTD section | read |
list_draftable_sections | CTD sections with enough evidence to draft | read |
draft_section | Draft a section; streams progress, returns the cited draft | write |
get_section | Read an existing draft, its citations, flags and table | read |
edit_section | Replace, insert, delete or cite sentences; authored text must cite claims | write |
refine_section | Rework a section with instructions and pinned evidence | write |
extract_evidence | Extract claims from a passage you point to | write |
get_vocabulary | Controlled values corrections may use | read |
update_document | Move a document to a section, attach it to a study, rename it | write |
update_study | Correct a study's metadata | write |
update_claim | Re-tag, re-type, re-word or clear the flag on a claim | write |
add_claim | Author a claim from a named document and page | write |
delete_claim | Remove a claim that should not exist | destructive |
mark_reviewed | Record a review verdict on a flagged table | write |
repair_document | Audited repairs to parsed structure: stitch tables, insert columns, set cells, header rows, heading levels, card fields | destructive |
Plans and usage
Start free, then Standard at $99/month or Pro at $299/month, each one seat and one program. Submission assembly, the consistency pass, the full provenance record and compiled export are on the Indago platform.
On the free tier, ingest, search, reading, provenance and manual editing are unmetered. Metered actions draw on a lifetime allowance: one net-new section draft, and a 200-unit usage pool where a question costs 2 units and an AI rework costs 25. Ask "How much allowance do I have left?" at any time; checking is free. When an allowance runs out, the tool returns a plain message saying what ran out, what you keep, and how to upgrade. Nothing is deleted.
Security and privacy
- Your files stay in Indago. Source documents upload to the Indago app, never through the chat. What crosses into Claude is what the tools return: excerpts, citations, tables, drafts and answers.
- OAuth sign-in. The connector uses OAuth with your Indago account. Claude never holds your Indago password. Disconnecting revokes the connector's access.
- Tenant isolation. Each customer's records live in a dedicated database schema with cross-tenant reads refused by the database itself, and documents sit under a separate prefix in object storage.
- No training on your data. Your documents, extracted evidence and drafts are not used to train models, ours or a provider's.
- Every write is logged with the caller's identity and note, and drafts get a new version, never an overwrite.
Details: Compliance & Security, Privacy Policy, Acceptable Use Policy.
Known limitations
- After an Indago deployment you may be asked to reconnect the connector. Reconnect from the Connectors page; nothing in your workspace is affected.
- A single drafting call is capped at five minutes. If a long section exceeds it, ask Claude to read the section; the finished draft is stored server-side.
- Cell edits on generated tables other than stability tables, re-classifying a passage independently of its claims, and Word export are done in the Indago app, not through the connector.
- Indago reads PDF and Word files. Scanned documents without a text layer are processed with layout recognition and flagged where the reading is uncertain.
Support
- Help and questions: hello@indago.bio
- Privacy, security and abuse reports: privacy@indago.bio
- Service status: status.indago.bio
- Connector endpoint:
https://mcp.indago.bio/mcp