The chat-native studio
for regulatory
writers.
Stop editing alone. Generate, refine, search, review, and QC CSRs, PSURs, and CERs in one conversation — with an agent that lives in your draft.
Or email us directly →Asthra is the chat-native studio for regulatory writers. Life-sciences teams generate, refine, search, and QC first drafts of CSRs, PSURs, and CERs — with CMC Module 3 in active development — from writer-specified source documents inside Microsoft Word. Every output is grounded in your evidence, cited at the sentence level, and packaged with an end-of-run QC report and a regulatory-grade run bundle.
Teams working in regulated life‑sciences documentation.
Clinical & Regulatory Writers
Pharmacovigilance Teams
Regulatory Affairs Teams
CROs & Service Providers
Device Vigilance Teams
Built by regulatory operators and AI engineers. Meet the team →
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.
Chat-native studio
One conversation, one document. See every section's state at a glance, ask any question in plain language, and approve consequential actions before they happen. No mode-switching between panels.
Walk-away drafting
Start the run, step away. Asthra lands a first draft with bibliography, hyperlinks, and a QC report ready in 1–2 hours. Come back to the studio with the full agent history, every tool call, and every gap flag in view — then review, refine, and finalise right where the agent left off. The draft is a starting point, not the finish line.
Tables & figures, in the chat
Ask the agent to summarise an adverse-event line listing, build a frequency table by system organ class, or chart sales exposure over time. Deterministic Python runs the analysis — every step audit-logged — and the resulting table or figure drops straight into the draft. No manual filtering, no LLM-fabricated numbers.
Literature search in the draft
Ask the agent mid-draft to find recent papers on a topic; it queries PubMed, ClinicalTrials.gov, and bioRxiv in parallel and surfaces citation-ready results — every external lookup writer-approved and ledger-logged.
Reviewer personas as skills
Summon an FDA Clinical Reviewer, CMC Reviewer, CER Device Reviewer, or CSR Writer QC over any section. Personas are SME-authored as markdown skills — your domain experts extend the studio, no engineering required.
Hyperlinks at draft time
Every “see Table 14.3.1.2” is wired to a stable anchor as the section is written, not weeks later in publishing. eCTD B21-ready cross-references that re-derive automatically when sections move.
End-of-run QC + run bundles
Every run finishes with a structured quality pass — checking cross-reference integrity, source-anchored claims, citation density, and gap detection — and ships as an audit-ready package: the draft itself plus the full trail of how it was produced.
An agent that plans, retrieves, drafts —
then a writer who reviews and hands off.
Five steps — every one of them auditable. The agent does steps 01–03; the writer drives step 04 with skills and reviewer personas; step 05 seals and delivers.
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
Asthra drafts each section against module-specific writing instructions your team validated during onboarding. Missing data is flagged inline, never fabricated. The first draft lands in Word with the citation graph already wired.
Review & refine
The writer drives the draft to finished. Refine through chat. Summon reviewer personas — FDA Clinical, CMC, CER Device, CSR Writer QC — over any section. Pull recent literature mid-draft. Run end-of-run QC. The studio is where the writer finalises.
Hand off
Seal the run as an audit-ready bundle: the .docx, per-section provenance, the QC report, and a run manifest. Every claim traces back to source. The ledger stays with the document — portable, vendor-independent.
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 — and what's coming next.
Clinical Study Reports
Full CSR first draft from trial protocol and TFL set. ICH E3 aligned.
Learn more →Clinical Trial Protocols
ICH M11–structured protocols from your concept, IB, and analysis strategy. Estimands kept consistent.
Learn more →Investigator's Brochures
ICH E6(R3) IBs synchronising toxicology, human PK, and reference safety information.
Learn more →PSUR / PBRER (pharma)
Aggregate safety reports from historical PSURs, CDS, exposure and safety data. ICH E2C(R2) aligned.
Learn more →DSUR (investigational)
ICH E2F development safety update reports from study-level safety data, exposure, RSI, and the prior DSUR.
Learn more →Device PSURs
EU MDR PSURs integrating sales, vigilance, PMCF, and literature into one safety narrative.
Learn more →Clinical Evaluation Reports
CERs for medical devices — EU MDR aligned. From literature review to PMS integration.
Learn more →Informed Consent Forms
Adult and pediatric ICFs — 21 CFR 50 and EU CTR compliant, in genuine lay language.
Learn more →Case Report Forms
CDISC CDASH–aligned CRFs from your protocol, with fields that map cleanly to SDTM.
Learn more →Briefing Documents
Pre-IND and Advisory Committee packages — benefit-risk narrative, positions on FDA questions.
Learn more →CMC (Module 3)
Consolidate BMRs, CoAs, specifications, and stability data into structured Module 3 content. In active development.
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
GDPR and HIPAA compliant. SOC 2 Type 1 and ISO 27001 ready. SOC 2 Type 2 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.
How the studio works, in depth.
Literature search inside the draft
PubMed, ClinicalTrials.gov, and bioRxiv — reachable from inside the chat without the browser-tab detour.
Hyperlinks belong in the draft
Cross-references wired up at write time, not weeks later in publishing. eCTD B21-ready by construction.
From prompt engineering to standards engineering
Why a versioned skill registry — not a chat box — is the right shape for AI in regulatory writing.
Frequently asked
Common questions about hallucination prevention, security, and integration.
Data security & AI controls
Architecture, encryption, retention, sub-processors. The working reference for security & IT-risk reviewers.
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.