We're building the writing layer for regulated science.
Asthra was founded by a team that has lived inside the regulatory writing process — and a team that has built large-scale AI systems. We bring those two worlds together so writers get leverage without losing trust.
Regulatory writing is one of the most consequential text-creation jobs in the world. A CSR can decide whether a drug reaches patients. A PSUR can flag a safety signal years before it would surface otherwise. The text matters — and the provenance of the text matters even more.
Generic AI doesn't fit this work. Hallucinations are a non-starter. Open-internet retrieval pollutes the source set. “Rewrite this paragraph” is not the unit of work that ships.
So we built Asthra around the actual unit of work: a section, drafted from a writer-approved source set, cited at the sentence level, reviewed by a human, and shipped with an audit ledger. Speed without compromising compliance.
How we build.
Writers stay in charge
The agent proposes; the writer disposes. Every retrieval plan, every source decision, every section is reviewable before anything ships. Asthra never overrides judgment.
Closed beats clever
We chose closed-system retrieval over the open internet, deterministic citations over plausible-sounding synthesis, and explicit gap flags over confident guessing. Less magic, more trust.
The ledger stays with the document
Audit readiness can't depend on a vendor staying in business. Every claim, every retrieval, every edit is captured in an append-only ledger embedded in the .docx itself.
Who's behind Asthra.
A small founding team of regulatory-writing operators and AI engineers. Backed by advisors from pharma safety, regulatory affairs, and applied AI.
Built on Claude. Designed for pharma.
Talk to the team.
We're early, focused, and selective about pilots. If your team writes regulated documents, we'd like to hear about your process.