Everything we publish, in one place.
Guides, whitepapers, articles, glossary, FAQs, and product comparisons — the full library of how Asthra thinks about AI in regulated writing. Start with a guide to learn the craft, a whitepaper for the long argument, or the blog for the running commentary.
Long-form positioning documents — the argument for why regulatory writing needs a different stack, and what that stack looks like.
Where Inference Enters the Record: Governing AI in Regulatory Writing
A sophisticated regulator is not asking whether you used AI. The question is where inference entered your document, and who owns it. How Asthra builds for that question — five modes of AI use, a control that fails closed, and a prompt-review failsafe.
Beyond Frontier Models — Why Regulatory AI Needs a Purpose-Built Stack
Frontier LLMs and generic RAG aren't enough for regulatory writing. A purpose-built stack — document model, retrieval, planning, and verification — is what separates a demo from a draft a regulator will accept.
Why Regulatory Writing Is Broken — And How Agentic AI Fixes It
Regulatory writing teams spend 60–70% of project time on mechanical document assembly while sponsors lose $1.4M per day of delay. Why generic AI tools fall short, and what an agentic, document-aware system actually changes.
Evergreen, plain-English guides to regulatory writing — the documents, the ICH guidelines behind them, and how to get into the field. The reference we wish existed.
Breaking into Regulatory Writing from the Lab, Pharmacy, or Clinic
Many regulatory writers came from the lab, pharmacy, or clinic. What transfers from each background, what's missing, and the concrete bridge move for each.
Read guide →CSR vs Clinical Overview: Two Very Different Documents
A CSR reports one trial in full under ICH E3 (Module 5); the Clinical Overview is a short benefit-risk argument for the whole program (Module 2.5).
Read guide →The CTD Explained: What Actually Goes in Modules 1–5
The Common Technical Document (CTD) organizes a drug submission into five modules. Here's what goes in each one, why 2.5 and 2.7 matter, and how eCTD fits.
Read guide →Articles, pilot debriefs, and regulatory news — written for medical writers, regulatory leads, and the people who hold them accountable.
The expedited lane is now the default. This has an implication on regulatory drafting.
More than 70% of last year's new drugs took an expedited path, and most of this month's designations are Fast Track or Orphan. The compressed timeline lands on a part of the process nobody plans for — the drafting.
Read article →FDA reversed its CRL pause in a week. That's not the part worth watching.
The FDA paused public release of Complete Response Letters, then posted 14 new ones days later. The policy will keep swinging. Meanwhile there were 455 rejection letters already in the public database when I checked, and almost no one drafting submissions is reading them.
Read article →Solving hallucinations won't make an AI regulatory-writing tool work
Everyone asks whether the AI hallucinates, and assumes that if it doesn't, the product works. A regulated document is a big, coherent argument grounded in real data — and getting a tool to actually help write one takes more than accuracy.
Read article →Definitions, common questions, and side-by-side comparisons against other tools.
Events
Where to meet Asthra in person — including the DIA Whale Tank at DIA 2026 in Philadelphia.
See events →Glossary
The terms regulatory writers and AI engineers use when they talk past each other — defined.
Open glossary →FAQ
Quick answers to the questions sponsors and writers ask before they pilot.
Read FAQs →Compare
How Asthra compares to generic copilots, in-house templates, and other regulatory AI tools.
See comparison →See Asthra on your documents.
Request a demo and we'll match Asthra's draft against your existing process — section by section.