Everything we publish, in one place.
Whitepapers, articles, glossary, FAQs, and product comparisons — the full library of how Asthra thinks about AI in regulated writing. Start with a whitepaper for the long argument; jump to 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.
Articles, pilot debriefs, and regulatory news — written for medical writers, regulatory leads, and the people who hold them accountable.
Build, Partner, or Purpose-Built: The Pharma AI Question Is Framed Wrong
Pharma leaders are increasingly asking whether to build AI in-house or partner with vendors. That framing is too narrow. The real question is architectural — does the system constrain sources, surface inference, preserve writer judgment, and produce provenance by default? A purpose-built regulatory-writing platform can be internal, vendor-led, or hybrid. What matters is what the architecture asks the writer to verify after generation.
Read article →GSK, Nuvalent, and the NDA Integration Problem Inside a Live PDUFA Window
GSK's $10.6B acquisition of Nuvalent brings two late-stage oncology NDAs already under FDA review: zidesamtinib, with a September 18, 2026 target action date, and neladalkib, with a November 27, 2026 target action date. The strategic logic is lung cancer. The writing problem is continuity — agency history, IR responses, labeling, and launch-facing documents now have to survive an ownership transition inside a live PDUFA window.
Read article →Biogen's Salanersen Breakthrough: What Licensed-Asset Writing Inheritance Looks Like in Phase 3
FDA granted Breakthrough Therapy Designation to Biogen's salanersen/BIIB115 for SMA on June 4, 2026. The once-yearly antisense oligonucleotide was discovered by Ionis and licensed to Biogen, which is now running three global Phase 3 studies. The writing-org story is how a licensee turns inherited early-development architecture into a coherent registrational dossier.
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.