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.
Two Advisory Committee Votes in Two Days: The Capricor and Replimune Record
On 29 and 30 July the same FDA advisory committee voted on two products and was asked a different question about each. Replimune was approved on 6 August after two prior rejections. Capricor's decision is due 22 August. A factual record of what was asked, what was voted, and what the approval rests on.
Read article →CBER updated the procedure your BLA has to survive. There is no redline.
SOPP 8401 governs what happens to an original BLA before the science gets its full review. Its effective date is now 29 July 2026. Sixteen of CBER's fifty-six published procedures carry a 2026 date in a year barely half over. There is no Federal Register notice, no docket, no comment period and no redline for any of them.
Read article →FDA challenged two sponsors' efficacy cases. One panel agreed, one didn't.
On consecutive days in late July, FDA advisers voted 9-3 against Capricor's deramiocel and 10-3 that Replimune's IGNYTE results were evaluable and clinically meaningful. Both sponsors walked in behind an FDA briefing document that publicly challenged their efficacy case. The agency's document set the terms of both arguments. It decided neither.
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.