Built for the scientist starting a company

You care about patients. We handle the back office.

You're spinning a discovery out of the lab. You know the science cold — but the IND, the quality system, the FDA meetings, the investor deck? That's our job. Istari drafts your reports, stands up your quality system, and guides you through the regulatory morass, so your invention reaches patients faster.

Five disciplines, one workspace — Forge · Ranger · Council · Steward · Lore

What we do for you

You bring the science. We bring everything around it — so you spend your days on patients, not paperwork.

Istari Forge

Your data, investor-ready

Turn lab data into reports and presentations investors believe. Upload your dataset, then revise by chat — every version saved.

Istari Ranger

Your path to the clinic

From your treatment to an IND-ready package: evidence dossiers, readiness checklists, study documents — generated from cited sources.

Istari Council

Regulatory without a regulatory department

Drafting grounded in FDA guidances, 21 CFR, and the full ICH library. Every claim traced to its source, so you can defend every word.

Istari Steward

A quality system from day one

Controlled documents, CAPA, audit prep — plus vendor management from your first CDMO: quality agreements, inspection history, and qualification status in one dossier.

Istari Lore

Every rule, in one library

FDA regulations, guidances, and all 71 ICH guidelines, searchable in one place. Stop Googling PDFs at midnight.

How it works

No regulatory team required.

1

Bring your science

Describe your treatment. We pull the cited evidence — FDA guidances, regulations, the ICH library, literature — into your dossier.

2

We draft, you review

Reports, protocols, SOPs, investor decks — drafted from your evidence and ready for your expert eye. You're the scientist; you stay in charge.

3

Revise by chat

Every document opens beside a chat box. Say what you want changed — each turn saves a new version, nothing is ever overwritten.

An honest note on compliance.
Istari workspaces are designed for 21 CFR Part 11 controls — tamper-evident audit trails, electronic signatures with re-authentication, role-based approvals. Independent qualification is pending and remains each customer's responsibility. We say exactly what the software does, and what it doesn't — ask us anything.

Pricing a seed budget can afford

Monthly billing, annual term. Start where you are; step up when compliance becomes non-negotiable.

Standard

$2,083/mo
Up to 10 seats

Validated

$6,250/mo
Up to 20 seats
Compare tiers
Beta program

Starting your company now?

We're onboarding founding teams. Approved early testers get free access via beta codes — bring your science, we'll bring the back office.

Try the demo