Know what's wrong before MOH does.
GALIAT is an AI-powered readiness check for Israeli Clinical Trial Applications. It reads your submission the way a Helsinki committee would — and tells you what to fix first.
It catches missing documents, contradictions between your protocol and your IB, consent forms, and Hebrew/English translation drift — before a committee or the Ministry of Health does. What used to take days of manual cross-checking happens in minutes, before you submit.
GALIAT analyzes dossier documents and identifies missing items and inconsistencies.
Built for every regulatory pathway
Whatever you're submitting, GALIAT derives the right document set from MOH Procedure 14.
New Drug
Form 1aSmall-molecule and biological drug trials — the richest conditional document rules of any pathway.
Medical Device
Form 1bMedical device trials, including registration-status and multi-site requirements.
Biological (Cell/Tissue-Based)
Form 1cAdvanced-therapy and cell/tissue trials — donor-origin and minimal-manipulation rules included.
Genetic
Form 1דGenetic and genomic research trials, including lab-abroad sample-handling documentation.
Most clinical-trial dossiers generate regulatory questions before approval.
Protocol–ICF inconsistencies represented 13–14% of participant-information queries.
BMC Medical Ethics, 2025
In a Spanish analysis of 100 clarification letters, 67.6% of requests concerned participant information or consent forms — and nearly one-third of those included translation-relevant issues.
Spanish ethics-committee analysis, 2015
Regulatory readiness shouldn't be a guessing game — GALIAT tells you exactly what's missing, inconsistent, or ready, before you submit.
What GALIAT catches
These are the kinds of findings GALIAT surfaces — the same format you'll see in your own submission's report.
How GALIAT works
Seven stages, each feeding the next — the same order a regulatory-affairs team would work through by hand.
- 01
Determine the pathway
A short questionnaire identifies your regulatory pathway — drug, device, biological, genetic, and more.
- 02
Build the checklist
GALIAT assembles the exact set of required documents for your pathway, derived from MOH Procedure 14.
- 03
Third-party documents, requested immediately
An email lists every document that must be requested from someone other than you, so you can start chasing them down right away.
- 04
Verify completeness
Your live checklist tracks exactly what's uploaded and what's still missing.
- 05
Cross-check the dossier
Every document is compared against every other for contradictions and translation drift, each finding backed by a cited passage.
- 06
Human review
A reviewer resolves, waives, or leaves each finding blocking — every decision permanently logged.
- 07
Final dossier package
Once approved, download the complete, submission-ready package in one click.
GALIAT key capabilities
Everything a regulatory-affairs team needs to move from onboarding to a submission-ready dossier.
Automatic pathway classification
Your onboarding answers determine the regulatory pathway — no guesswork.
Dynamic, pathway-specific checklist
Required documents are derived from MOH Procedure 14, including conditions specific to your trial.
Cross-document consistency check
Contradictions in identity, study design, safety, and numeric values are surfaced automatically.
Hebrew/English translation verification
Matched document pairs are checked for semantic equivalence, exact numbers, and omissions.
Reviewer sign-off & audit trail
Every finding is resolved, waived, or left blocking by a human — permanently logged.
One-click final package export
Once approved, download the complete, submission-ready document package.
Built for the people who file the submission
Biotech and medtech sponsors
Know your submission is complete before it leaves your desk.
CROs and regulatory consultants
Run the same readiness check across every sponsor's trial or client engagement.
Clinical & regulatory teams
Spend less time cross-checking documents, more time on judgment calls.
Security & confidentiality
Your dossier is proprietary, unpublished work. Here's how GALIAT protects it.
Encrypted data
All data is encrypted in transit between your browser and our servers.
Strict customer isolation
Every customer's data is isolated at the database level — not just hidden in the interface.
Private document storage
Uploaded documents are stored in private cloud storage and are never publicly accessible.
Controlled AI processing
All AI processing happens on our servers, under commercial terms that prohibit using your data to train AI models.
Auditable and traceable
Every upload, download, and reviewer decision is logged permanently, and every finding cites its source passage.
Role-based access
Platform administrators are kept separate from customer accounts, with every privileged action logged.
Know what's missing before you submit
Sign up and upload your documents, or talk to us first if you'd like a walkthrough.