Indago Regulatory Drafting Agent

Indago Regulatory Drafting Agent (IRDA) puts Indago's regulatory drafting engine inside Claude for teams preparing FDA submissions. Point it at your study reports, protocols, CMC data, and prior submissions. 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. What it does:

• Drafts Module 2 sections from your source documents, not from generic templates
• Traces every claim back to the source document and location, so a reviewer can verify a line without hunting for it
• Runs Gap Analysis against the target submission type and flags what is missing or thin before a reviewer finds it
• Reworks any section on request. Manual editing is always free and unmetered
• Keeps source material in your Indago workspace, with deep links back into the app for long documents

Who it's for: regulatory affairs teams at IND-stage biotechs, plus the consultants and CROs who file on their behalf. Built for people writing a Pre-IND, IND, or NDA/BLA right now who want a first draft in hours instead of weeks. A regulatory professional stays in the loop. IRDA produces working drafts for review, edit, and approval. It does not file anything on your behalf. Start free, then Standard at $99/mo or Pro at $299/mo, each one seat and one program. Submission assembly, the consistency pass, the full provenance record, and compiled export are on the Indago platform.