High-trust AI
for regulatory
submissions.
Asthra drafts CSRs, PSURs, CERs, and CMC modules inside Microsoft Word — grounded in your own source documents, with sentence-level citations and human review at every step.
Asthra AI is a regulatory writing co-pilot for life sciences teams. It generates compliant first drafts of clinical and safety documents — CSRs, PSURs, CERs, and CMC modules — from writer-specified source documents inside Microsoft Word. Every output is grounded in your evidence, cited at the sentence level, and subject to human review.
Teams working in regulated life‑sciences documentation.
Regulatory writing is still slow,
manual, and repetitive.
Generic AI doesn't fix it — it adds new risk. Teams need leverage, not chatbots.
Writers start from blank templates
Each document begins with manual review of protocols, trial data, and prior reports. Critical context lives across dozens of files — hours of synthesis before writing can begin.
Grunt work consumes writing capacity
Copy-paste, rewriting sections across documents, summarizing data tables, reformatting into templates. Seasoned writers spend 60% of their time on mechanical tasks instead of judgment.
Generic AI introduces new risks
General-purpose chatbots hallucinate, lose grounding in source material, and leave reviewers with no way to verify claims. In a regulated submission, unverifiable content is worse than no content.
Timelines compress, effort keeps rising
Regulatory deadlines tighten while document complexity grows. Teams hire more writers and add overtime, but cycle times don't improve — the underlying process stays manual.
Accelerate drafting —
without breaking compliance.
Asthra helps life-sciences teams generate structured first drafts from source content, with writer-defined provenance, on-demand citations, and human-in-the-loop review — so writers focus on judgment, not grunt work.
What Asthra delivers.
Drafts sections faster
Section-specific drafting aligned to your own templates. Choose your source documents, answer a few prompts, and generate a first draft in minutes.
Grounded in your evidence — not model memory
Outputs are generated strictly from writer-specified source documents. No unsupervised internet retrieval — external lookups require writer approval and are logged. No training-knowledge leakage. Missing data is flagged, never fabricated.
Works inside Word
No new authoring environment. Writers stay in Microsoft Word via the Asthra add-in. Launch, select sources, review the draft inline, edit in place.
Two-level citations, on demand
Every section is cited at the document level and, when you need it, at the sentence level — with file name, page number, and exact text snippet. Supports blind review workflows.
An agent that plans, retrieves,
drafts, and hands off.
Four steps — every one of them auditable.
Plan
The agent produces a retrieval plan: which source files and sections it intends to use for each part of the document. Review and approve the plan before drafting begins.
Retrieve
Semantic retrieval pulls the right excerpts from your uploaded documents. No unsupervised internet access — any external lookup pauses for explicit writer approval and is logged in the ledger. Nothing from model training memory. Only your evidence, on your terms.
Draft
Claude drafts each section against module-specific writing instructions your team validated during onboarding. Missing data is flagged inline, never fabricated.
Hand off
The draft lands in Word with an immutable transaction ledger. Every claim traces back to a source file, page, and passage. Writers edit in place with track changes.
Chat with your draft
after it's written.
After the first draft lands, Asthra stays in the document with you. Ask why it cited a particular passage, which sources it compared, or whether a claim has supporting evidence. Tell it to rework §4.1, tighten a summary, or swap one source for another.
Every refinement is logged, every citation updates automatically, and every edit goes through the same closed-system retrieval that produced the original draft.
Illustrative chat. Real conversations happen inside the Word add-in.
Where teams use Asthra today.
Clinical Study Reports
Full CSR first draft from trial protocol and TFL set. ICH E3 aligned.
Learn more →PSUR / PBRER / DSUR
Aggregate safety reports from historical PSURs, CDS, exposure and safety data.
Learn more →Clinical Evaluation Reports
CERs for medical devices — EU MDR aligned. From literature review to PMS integration.
Learn more →CMC (Module 3)
Consolidate BMRs, CoAs, specifications, and stability data into structured Module 3 content.
Learn more →Trust, transparency, and compliance.
Uses only the sources you provide
Closed to the internet by default and to model memory. Asthra operates within your data perimeter; external lookups require writer approval and are logged in the ledger. No source contaminates the output without your sign-off.
Flags missing or inconsistent data
When source documents contain gaps or contradictions, Asthra surfaces them explicitly — instead of papering over them with plausible-sounding text.
Two levels of traceability
Document-level provenance for every section, plus on-demand sentence-level citations with file, page, and passage. Every generated claim is audit-traceable.
Validation & compliance posture
SOC 2 Type 1 and ISO 27001 ready. SOC 2 Type 2, GDPR, HIPAA, and EU AI Act in progress. Deploy as managed SaaS or in your own VPC.
In active use with pharma and medical-device teams.
Named references available on request.
Pharmacovigilance teams are under increasing pressure to do more with greater speed and consistency. Asthra applies AI in a thoughtful, compliance-aware manner — automating the heavy lifting while keeping expert oversight central.
Learn more about AI in regulatory writing.
Writer-Defined Provenance
How Asthra keeps writers in control of every source decision.
Context Engineering
Why closed-system retrieval beats prompt engineering for regulated writing.
Citations that Hold Up
Two-level citations and what regulatory reviewers actually need.
Frequently asked
Common questions about hallucination prevention, security, and integration.
See Asthra on your documents.
Request a live demo and we'll match Asthra's output, side-by-side, against your existing process — and show you the writer-hours saved, line for line.