Study Start-up - Georgia

Medical Device / Pharma / Advanced Therapies (ATMPs)

Georgia

Starting a Clinical Trial in Georgia

A streamlined regulatory process designed to get your study running within 3 months.

STEP 1 3-5 weeks

Local Ethical Committee (LEC) Approval

Arranging the submission dossier usually takes 3-5 weeks. The review process in the LECs takes an additional 1-2 weeks. LEC approval is required from each study site before proceeding.

STEP 2 ~3 weeks

Ministry of Health (MoH) Submission

The review of your study in the MoH will take about 3 weeks. LEC approval is a prerequisite for this submission.

STEP 3 2-3 weeks (parallel)

Site & Investigator Agreements

Agreements with study sites and investigators is done in parallel to the regulatory approval process. We can assist you with the agreement negotiations.

STEP 4 Issued with MoH approval

Study Approval & Import Permit

The import permit is issued together with the study approval certificate from the Ministry of Health. No separate step required.

Study Start-up Timeline - Georgia
Within 8-12 weeks from dossier preparation to site initiation.
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Ready to Launch Your Study in Georgia?

Our team will guide you through every step of the process.

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