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.
AbbVie's $10.9B Move for Apogee: What Happens to the Dossier When a Clinical-Stage Program Changes Hands Mid-Development
AbbVie is acquiring Apogee Therapeutics for $10.9B, centered on zumilokibart / APG777, a half-life-extended anti-IL-13 antibody with Phase 2 atopic dermatitis data and broader potential in asthma and EoE. The regulatory-writing problem is not ordinary bolt-on cadence. It is a living-dossier handoff: open IND history, IB revisions, active trials, safety updates, and agency correspondence must move into AbbVie's system without losing continuity.
Read article →Operation TrialBlazer and Phase-Appropriate Requirements: What FDA's Modernization Push Asks of the Writing Organisation
FDA's Operation TrialBlazer aims to accelerate drug development from the pre-IND / IND transition through late-stage trials, with a Phase 1 IND Navigator, updated Phase 1 CMC resources, dose-selection guidance, master-protocol updates, and an explicit focus on phase-appropriate requirements. For regulatory writing teams, the implication is direct: every section now has to be scoped to the phase deliberately, with clear deferral language and reviewer-visible rationale.
Read article →Regenxbio Resubmits Its Hunter Syndrome Gene Therapy Without a New Study: The Rare-Disease Resubmission Pattern Takes Shape
Regenxbio plans to resubmit NAVSUNLI / RGX-121 for Hunter syndrome without enrolling additional patients or running a new study, after FDA indicated the existing data could support accelerated approval. Coming days after FDA reopened uniQure's AMT-130 path, the move signals a more flexible rare-disease posture. The resubmission dossier now has to reconcile the prior CRL, make the existing evidence load-bearing, and carry a credible confirmatory plan.
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.