An agent built for regulated writing.
Asthra is a four-step agentic loop, designed end-to-end for the constraints of regulatory submissions: closed-system retrieval, human-in-the-loop review, and audit-ready provenance on every claim.
Asthra writes a retrieval plan first — you approve it before it drafts a word.
Before generating any text, Asthra produces a plan: which source documents it intends to consult for each section of the deliverable. Writers review the plan, swap sources, exclude material out of scope, and approve.
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Section-by-section retrieval mapping with source-file pinning
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Edit, swap, or exclude sources before drafting begins
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Plan is captured in the audit ledger and reproducible
Closed-system semantic retrieval — your sources, only.
Asthra indexes the files you upload and pulls the right excerpts via semantic retrieval. No unsupervised internet access, no fallback to pretrained knowledge, no cross-tenant leakage — only the documents you specified. If an external lookup is genuinely needed, Asthra pauses and asks the writer to approve a specific request before fetching anything; the approval and the result are recorded in the audit ledger.
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Section-aware semantic search, scoped to your document set
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Tables, figures, and structured data ingested alongside narrative
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Every retrieval returns a passage, page, and offset — recorded in the ledger
Section-specific drafting — never invented, always cited.
Claude drafts each section against module-specific writing instructions your team validated during onboarding. Every claim is bound to a retrieved passage. Where data is missing, Asthra surfaces an explicit gap flag rather than inventing plausible-sounding text.
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Module-specific writing rules (ICH E3, EU MDR, ICH M4Q) applied per document type
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Two-level citations: document-level by default, sentence-level on demand
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Inline gap flags for missing or contradictory source data
9.4 Adverse Events
Treatment-emergent adverse events were reported in 284 patients (88.5%) in the pembrolizumab arm and 295 (91.9%) in the docetaxel arm1.
Grade 3 or higher events occurred in 13.4% of pembrolizumab patients versus 35.0% of docetaxel patients2.
Subgroup analysis for patients aged ≥75 years ⚠ data gap — TLF-AE-03 missing
The most common immune-related events were hypothyroidism (8.1%) and pneumonitis (4.7%)4.
A draft you can audit — line by line.
The draft lands in Word with an immutable transaction ledger. Every plan change, retrieval, draft step, gap flag, and edit is recorded with a timestamp, actor, and target section. The ledger stays with the document — independent of Asthra — so audit readiness survives the vendor.
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Append-only ledger embedded in the .docx as a side-channel attachment
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Each citation resolves to a file, page, and exact passage
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Track changes capture every writer edit alongside the agent record
Built on Claude — wrapped in regulated-writing guardrails.
Foundation models alone don't ship in regulated environments. Asthra adds the orchestration layer, the closed-system retrieval, the citation graph, and the ledger that turn a capable model into an audit-ready writing agent.
See Asthra
on your documents.
30-day pilot. We benchmark Asthra's output against your existing process — and show you the writer-hours saved, line for line.