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.
FDA showed you the safety lens its reviewers use. Your ISS may be using another one.
CDER posted two on-demand webinars in June with no announcement: one on the standard safety tables and figures guide, one on the 104 Office of New Drugs Custom Medical Queries used for safety signal detection. They aren't requirements. They are a description of what happens to your adverse event data after it arrives.
Read article →Five sources moved in five weeks. That's a provenance problem.
A withdrawn guidance, an advisory committee whose charter lapsed, two retracted papers, a set of journal articles the agency has now disowned, and a rejection-letter programme that paused and restarted. Regulatory documents record what they depend on. They can't tell you what depends on them.
Read article →FDA says CMC readiness is the bottleneck. The pilot built for it is running out of road.
On 23 July FDA published a strategy document naming CMC readiness as the thing that breaks on accelerated timelines. The same week it emerged that the pilot built for exactly that problem is winding down, undersubscribed, after three years. In the published rejection letters, 65% cite facility deficiencies and 51% cite CMC — against 26% for efficacy.
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.