AI agents that plan, draft and QC your regulatory documents.
Point Asthra at your source documents. It plans what to retrieve, drafts each section, cites every sentence to file and page, and runs QC on its own work. CSRs, PSURs, CERs, protocols, IBs and more, with a first draft in 1–2 hours. You approve the plan and review the result.
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“The quality of the draft and the speed at which it was produced genuinely impressed me. It will supplement and speed up how we work, and over time become part of our core writing workstream — this is where regulatory writing is heading.”
Chief Medical Officer, Renibus Therapeutics
In active use with pharma and medical-device teams. Named references available on request.
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.
General-purpose AI tools haven't fixed this, and in a regulated submission they add risk of their own.
Writers start from blank templates
Each document begins with manual review of protocols, trial data, and prior reports. The context a writer needs is spread across dozens of files, so hours go into synthesis before any writing starts.
Grunt work consumes writing capacity
Copy-paste, rewriting sections across documents, summarizing data tables, reformatting into templates. Experienced writers lose much of their week to mechanical work that needs none of their judgment.
Generic AI introduces new risks
General-purpose chatbots hallucinate, drift away from the source material, and give reviewers no way to verify a claim. In a submission, a sentence nobody can verify is a liability.
Timelines compress, effort keeps rising
Regulatory deadlines tighten while document complexity grows. Teams hire more writers and add overtime, but cycle times stay flat because the underlying process is still manual.
Faster first drafts
that stand up to an audit.
Asthra helps life-sciences teams generate structured first drafts from source content, with the writer choosing the sources, citations available for every sentence, and a human reviewing every section before it goes anywhere.
What Asthra does.
Drafts while you do something else
Start a run and step away. In 1–2 hours you have a first draft in Word with a bibliography and a QC report.
Reviews the draft the way a regulator would
A section-by-section check against ICH E3 expectations and approved-label precedent from openFDA. Flags are ranked by severity and pinned to the paragraph they concern.
Builds tables and figures from your data
Ask for an adverse-event frequency table by system organ class or an exposure chart. Python does the arithmetic and every step is logged, so no number comes from the language model.
Hands over an audit package with the draft
Each run ends with a QC pass over cross-references, citations and gaps. You get the .docx together with the record of how every section was produced.
Also in Asthra: literature search across PubMed, ClinicalTrials.gov and bioRxiv, named versions you can compare and restore, and real-time co-editing with comments. See the full product →
Asthra plans, retrieves and drafts.
The writer reviews and signs off.
Plan
Asthra lists which source files and sections it will use for each part of the document. You approve the plan before drafting begins.
Retrieve
Excerpts come only from the documents you uploaded. Nothing comes from the open internet or model memory unless you approve a specific lookup.
Draft
Each section is drafted against writing instructions your team validated during onboarding. Missing data is flagged inline, never filled in.
Review & refine
You take the draft to finished, in Word or the web app: resolve the flags, regenerate a section, rewrite a highlighted passage, and pull recent literature. Every change is a diff you accept or reject.
Hand off
Export the .docx with per-section provenance and the QC report. The record travels with the document and does not depend on Asthra.
The first draft is
where your work starts.
Review and refinement takes longer than drafting, so Asthra stays in the document with you. When a protocol or SAP is amended, add the new version and regenerate the sections it touches. Work through the flags, rewrite a highlighted paragraph, or ask why a passage reads the way it does. Every change Asthra makes comes back as a tracked change or a diff you accept or reject.
- Resolve a flag where it sits. Ask Asthra to fix it, write it yourself, or dismiss it. Every fix is a diff you accept or discard.
- Or clear a whole document. Start a pass over many sections. Nothing is applied until you approve each proposal.
- Regenerate a section, with steering. A protocol or SAP was amended? Add the new version, steer the re-draft, then keep it or revert.
- Rewrite what you highlight. Select a passage, say what you want, and review the before and after.
- Ask the draft anything. Ask why a passage reads the way it does. The answer keeps the steps it was built from.
- Name a version, compare, restore. Freeze a named version, compare it with the current draft, restore a section or the whole thing.
Adverse events were analysed in the per-protocol population (N=298; SAP v1.3 §4.2). Grade 3 or higher events occurred in 14.1% (42/298). Adverse events were analysed in the ITT population (N=321; SAP v2.0 §4.2). Grade 3 or higher events occurred in 13.4% (43/321; TLF-AE-01, p.42).
Illustrative chat. Real conversations happen in the Word add-in and the web app.
Documents teams draft with Asthra today.
Clinical Study Reports
Full CSR first draft from trial protocol and TFL set. ICH E3 aligned.
Learn more →PSUR / PBRER (pharma)
Aggregate safety reports from historical PSURs, CDS, exposure and safety data. ICH E2C(R2) aligned.
Learn more →Clinical Evaluation Reports
CERs for medical devices, EU MDR aligned, from literature review to PMS integration.
Learn more →Device PSURs
EU MDR PSURs integrating sales, vigilance, PMCF, and literature into one safety narrative.
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 →Trust, transparency, and compliance.
Uses only the sources you provide
Closed to the internet and to model memory by default. Asthra works inside your data perimeter, and any external lookup needs the writer's approval and is logged.
Flags missing or inconsistent data
When source documents contain gaps or contradictions, Asthra points them out instead of papering over them with plausible-sounding text.
Traceable down to the sentence
Every section records which documents it drew on, and any sentence can be traced to its file, page and passage on request.
Validation & compliance posture
SOC 2 Type 2 attested. GDPR and HIPAA compliant. ISO 27001 ready; EU AI Act in progress. Deploy as managed SaaS or in your own VPC.
Asthra is an agentic AI platform for regulatory writing. Life-sciences teams use it in Microsoft Word or the Asthra web app to generate, refine, search and QC first drafts of CSRs, PSURs, CERs, protocols and IBs from source documents the writer specifies, with CMC Module 3 in development. Every output is grounded in your evidence, cited at the sentence level, and delivered with a QC report and a full record of how it was produced.
How Asthra works, in depth.
Literature search inside the draft
PubMed, ClinicalTrials.gov, and bioRxiv — reachable from inside the chat without the browser-tab detour.
Asthra resolves the flags it raises
Point it at the source, and every fix comes back as a tracked change you accept or reject.
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.
Sign in and try Asthra on our sample study libraries. They are fully free, and you see how a draft is built and cited before you upload a file of your own. Writing as a team? Book a demo and we'll run it on your documents with you.