Asthra AI

Asthra is the chat-native studio for regulatory writers.

Life-sciences teams generate, refine, search, review, and QC first drafts of CSRs, PSURs, CERs, clinical trial protocols, Investigator's Brochures, and more — in one conversation, inside Microsoft Word. The agent lives in your draft: it plans which sources to use, retrieves only from your own documents, drafts each section against your house rules, and cites every claim at the sentence level.

What makes Asthra different:

• One conversation, one document — generate, refine, search, and review without switching tools.

• Walk-away drafting — start a run, step away, and return in 1–2 hours to a first draft with bibliography, hyperlinks, and a QC report ready.

• A dedicated QC agent — every run ships a structured quality report that cross-checks every claim against its sources and enforces cross-section consistency.

• Reviewer personas — summon an FDA Clinical, CMC, CER Device, or CSR Writer QC reviewer over any section before the real review.

• Audit-ready by construction — closed-system retrieval over your own sources, sentence-level citations, and a run bundle you can hand to an inspector.

Built for regulated writing, not adapted to it. Part 11–ready architecture. SOC 2 ready. Your sources, your perimeter.

Learn more: https://asthra-writer.ai