How much time and money will we actually save?

Teams can recover 100+ hours and avoid $150-250K in rework, contractor spend, and filing delay costs on a typical IND, NDA, 510(k), or De Novo submission cycle by using Assyro to reduce drafting rework, validation delays, and manual coordination across biopharma and medical device workflows.

What if our submission still gets rejected?

Assyro helps teams catch technical and readiness issues before filing by validating eCTD structure, lifecycle, and metadata for biopharma submissions, and tightening eSTAR completeness, evidence packaging, and filing readiness for medical device submissions before sending to FDA.

Do you support submissions outside the US?

FDA workflows are fully supported today, and the platform is built around a multi-jurisdiction submission model with support extending to EMA and Health Canada.

Is our data secure enough for regulated submissions?

The platform is built for regulated environments with end-to-end encryption, 21 CFR Part 11 aligned audit trails, and EU Annex 11 compliance for auditable submission workflows.

Can we test it on a real submission before committing?

Yes, Assyro offers a pilot-first approach where you can start on one workflow and one submission stream, then expand when you see results.

Fact sheet · Compliance & audits

Assyro AI

AI regulatory submission software that cuts 6+ weeks and $250K of rework from every submission cycle

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AI regulatory submission workspace for pharma, biotech, and medical device teams to draft faster, validate earlier, and keep submissions audit-ready.

Overview

Screenshot of the Assyro AI homepage — What assyro.com looks like

Assyro AI is an AI regulatory submission software platform designed for pharma, biotech, and medical device teams. It helps teams draft regulatory submissions faster, catch eCTD and eSTAR defects earlier, and keep filings audit-ready through a shared workspace. The platform integrates with existing systems like SharePoint, Box, and Google Drive to keep source documents synced, tracks submission readiness in real time, runs deadline-driven workflows automatically, and maintains 21 CFR Part 11 and EU Annex 11 compliance. Teams can coordinate multiple programs across jurisdictions including FDA, EMA, and Health Canada submissions.

Feature facts

Connect and sync source documents across SharePoint, Box, Google Drive, and other systems
Real-time submission readiness tracking combining validation findings, drafting progress, and risk signals
Automated deadline-driven workflows with validation, drafting, routing, and readiness checks at T-30, T-14, and T-3
21 CFR Part 11 and EU Annex 11 compliant audit trails with role-based access
eCTD structure, lifecycle, and metadata validation before submission
eSTAR completeness, evidence packaging, and filing readiness validation for medical devices
Multi-jurisdiction coordination with FDA, EMA, and Health Canada workflow support
Sponsor isolation controls for CROs with separate document storage, access controls, and audit trails per sponsor
Sponsor read-only dashboard for real-time program status and readiness scoring
Repeatable workflows and pre-configured templates for rapid sponsor onboarding

Pricing

Pricing model: Contact for pricing

Custom pricing based on workflow mix and rollout scope with unlimited users on every plan. Pilots available with tailored proposal within 1 business day of pricing call.

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Assyro AI specifications

Specifications of Assyro AI
Section	Compliance & audits
Founded	2024
Stage	Startup
Website	assyro.com
Votes²	0

Assyro AI metrics

Fact file for assyro.com: Ahrefs Domain Rating and Majestic link facts, each with the change since the last fact check.
Metric	Value
Domain Rating	31 −1 (down) since last check
Trust Flow	23 no change since last check
Citation Flow	40 no change since last check
Referring domains	415 no change since last check
External backlinks	1,299 no change since last check

Fact: Ahrefs Domain Rating checked 12 Nov 2026, fact changed 8 Nov 2026. Fact: top topic Business/Industrial Goods and Services (23). Fact: Majestic checked 18 Oct 2026, fact changed 18 Oct 2026. Link facts from Majestic. Trust Flow, Citation Flow and Topical Trust Flow are trademarks of Majestic-12 Ltd.

Assyro AI domain fact sheet

Open the fact sheet

Read from the public RDAP record on 11 Nov 2026, 04:57 UTC.
Domain age	1 year
Registered	5 May 2025
Expires	5 May 2027
Registrar	Cloudflare, Inc.
DNSSEC	Not signed

Every domain fact for assyro.com

Assyro AI launch receipt sheet

What we have measured for Assyro AI since it went live on SaaS Directory Info on 18 October 2026.

31 Domain Rating (Ahrefs) −15 (down) since launch
at launch: 46 (18 Oct 2026); latest: 12 Nov 2026
23 Trust Flow (Majestic)
first measured 18 Oct 2026
415 Referring domains (Majestic)
first measured 18 Oct 2026

Day 25 since launch. Next receipt: day 30, 17 Nov 2026. The figures report a change; they do not say what caused it, and many things can. No figure here is a guess.

Biggest gains on SaaS Directory Info

Got a launch coming up?

Step-by-step tips for before, during and after your launch, free to read on SaaS Directory Info.

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Frequently looked up

Q1How much time and money will we actually save?: Teams can recover 100+ hours and avoid $150-250K in rework, contractor spend, and filing delay costs on a typical IND, NDA, 510(k), or De Novo submission cycle by using Assyro to reduce drafting rework, validation delays, and manual coordination across biopharma and medical device workflows.
Q2What if our submission still gets rejected?: Assyro helps teams catch technical and readiness issues before filing by validating eCTD structure, lifecycle, and metadata for biopharma submissions, and tightening eSTAR completeness, evidence packaging, and filing readiness for medical device submissions before sending to FDA.
Q3Do you support submissions outside the US?: FDA workflows are fully supported today, and the platform is built around a multi-jurisdiction submission model with support extending to EMA and Health Canada.
Q4Is our data secure enough for regulated submissions?: The platform is built for regulated environments with end-to-end encryption, 21 CFR Part 11 aligned audit trails, and EU Annex 11 compliance for auditable submission workflows.
Q5Can we test it on a real submission before committing?: Yes, Assyro offers a pilot-first approach where you can start on one workflow and one submission stream, then expand when you see results.

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