Fundamentals.
4 articles on fundamentals — analysis from the Asthra team and our advisor network.
2026
What Is Regulatory Writing Automation? A 2026 Definition for Life Sciences
Regulatory writing automation is the use of AI to draft, cite, and QC regulated documents like CSRs, PSURs, DSURs, CERs, and CMC modules. Definition, examples, and what to look for in 2026.
2026
When 'Zero Citations' Is the Wrong Alarm
Our grounding metric read near-zero on the sections we'd grounded most carefully. We spent a week 'fixing' the drafting before we realized the number was lying — not about the drafts, about itself. The lesson: a confident, wrong metric is worse than no metric.
2026
From Prompt Engineering to Standards Engineering
The first wave of AI in regulatory writing was the chat box. We built a versioned skill registry instead — and it is becoming the system-of-record for how regulatory standards apply to a draft.
2026
In Vivo Cell Engineering at ASGCT 2026: The IND-Enabling Writing Problem Behind the Science
ASGCT 2026 showed growing momentum around in vivo cell engineering, from in vivo CAR-T to gene writing and gene regulation platforms. The science is advancing quickly, but the IND-enabling writing challenge is still unresolved: how do sponsors build CMC and nonclinical narratives when the precedent base is thin and borrowed from adjacent modalities?
See it on a real CSR, PSUR, or CER.
Asthra's five-step loop — Plan, Retrieve, Draft, Review & refine, Hand off — running on real regulatory documents, not slides.