Your AI-Powered
Regulatory Review
Expert
Upload your protocol or consent form. In minutes, get a detailed compliance report with PASS, WARN, and FAIL findings — each mapped to the exact federal regulation and document section. Catch issues before they become delays.
From document to compliance report in minutes
Upload your research document, let the AI analyze it against federal regulations and institutional rules, and get a detailed compliance report — whether you're preparing a submission or reviewing one.
Upload Your Document
Upload your protocol, consent form, or regulatory document in PDF format.
AI Reviews for Regulatory Compliance
Our AI reviews your document against federal regulations and your institution's custom rules. Every finding is mapped to the specific regulation and document section.
Get Your Review Report
Receive a detailed report with PASS, WARN, and FAIL findings — each citing the exact regulation and document section, so you know precisely what to fix.
Built for everyone in the research compliance process
Whether you're preparing a submission or reviewing one, Sunethics.ai helps you get it right the first time.
Researchers & Students
Submit with confidence
Pre-check your protocols and consent forms against federal regulations before you submit to the IRB. Catch issues early, reduce revision cycles, and get to approval faster.
- AI reviews your document against the same regulations your IRB uses
- Every finding cites the exact regulation and document section
- Reduce back-and-forth and speed up the path to approval
IRB Offices & Review Teams
Your thoroughness, amplified
Handle growing submission volumes with confidence. AI pre-screens every document against federal regulations and your institution's custom rules — surfacing potential issues so your team can focus expertise where it matters most.
- Every regulation checked consistently, every time
- Add your institution's custom rules on top of federal baselines
- Audit-ready reports with full traceability
AI-powered review, built for clinical research
Comprehensive regulatory analysis in minutes — plus the tools to manage your entire compliance workflow.
AI Regulatory Reviews
The core of Sunethics.ai. Upload any research document and get a detailed compliance report in minutes — every finding mapped to the exact regulation, section, and page.
Custom Rule Engine
Add your institution's specific requirements on top of federal regulations. Organization rules, site-level overrides.
Real-Time Streaming Results
Watch your AI review run live — see every PASS, WARN, and FAIL finding as it's discovered. Full transparency, no black boxes.
Submission WorkflowPlus
Need workflow too? Route documents through reviewers with built-in approval tracking, comments, and full history.
Audit-Ready Reports
Every review is logged with rule version snapshots. Show auditors exactly what was checked and when.
Multi-Site ManagementPlus
Running multiple sites? Manage AI reviews, rules, and teams across all your research locations from one dashboard.
Choose the right path for you
Whether you're an individual researcher or a large organization, we have a plan that fits.
For students, PIs, postdocs, and independent researchers. Sign up instantly — no setup call needed.
- 10 AI regulatory reviews per month
- Federal regulation checks (45 CFR 46, 21 CFR 50/56, ICH E6, HIPAA)
- Email support
- 30 AI regulatory reviews per month
- Everything in Starter
- Submission workflow
- Priority support
- 60 AI regulatory reviews per month
- Everything in Professional
- Cross-site management
- Custom rule authoring
- Dedicated support
Choose a plan that fits your research workflow.
IRB offices, research sites, health systems, CROs, and sponsors — we'll configure everything for you.
Built for your organization
- Dedicated onboarding with a Compliance Advisor
- Custom user quotas and site configuration
- Volume pricing for your team
- AI Reviews + Workflow, configured to your needs
- Cross-site management and custom rule authoring
- Priority support with a dedicated account manager
Talk to a Compliance Advisor
Prefer email? Reach us at solutions@sunethics.ai
Thank you!
A Compliance Advisor will reach out within one business day.
Advancing healthcare through smarter regulatory review
Every day, dedicated professionals work to ensure clinical research meets the highest ethical and regulatory standards. But growing submission volumes, evolving regulations, and limited resources make it harder than ever to be thorough.
Sunethics.ai gives research teams an AI-powered advantage. Our platform catches regulatory gaps in minutes — so reviewers can focus their expertise on the complex judgments that matter most, and researchers can submit with confidence that their work meets the bar. Better tools. Faster approvals. More time for what truly matters: advancing healthcare for the communities that need it.
