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.
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.
CNPV Pilot at Seven Approvals: Bizengri and the Priority Voucher Pathway
The FDA's Commissioner's National Priority Voucher pilot just landed its seventh approval with Bizengri for NRG1-fusion cholangiocarcinoma. A June 4 public hearing will shape what comes next.
Read article →FDA's Drug Repurposing RFI: Why This Is a Regulatory Writing Opportunity
The FDA opened a docket on May 13 asking for drug repurposing candidates — explicitly inviting AI/ML preclinical evidence. Comments are due through June 29. The window matters more than the form.
Read article →From IPO to First Annual Report: The Disclosure Stack Newly Public Biotechs Miss
An IPO doubles a biotech's disclosure workload overnight. The regulatory writing function rarely gets re-resourced in time. Here is what gets missed and how to plan against it.
Read article →Definitions, common questions, and side-by-side comparisons against other tools.
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.