Study Start-up - Armenia

Medical Device / Pharma / Advanced Therapies (ATMPs)

Pharma & Advanced Therapies (ATMPs)

Pharma Trial Start-up

STEP 1 3-5 weeks

Submission Dossier

First step is arranging the submission dossier which usually takes 3-5 weeks.

STEP 2 40-70 days

Ministry of Health (MoH) Review

We submit the dossier to the Armenian Ministry of Health. The review process and study approval takes 40-70 days.

Medical Devices

Device Trial Start-up

STEP 1 3-5 weeks

Submission Dossier

First step is arranging the submission dossier which usually takes 3-5 weeks.

STEP 2 ~4 weeks

Sequential Submission (CEC then MoH)

We submit first to the Central Ethical Committee (CEC), and once CEC approval is obtained, we submit to the Armenian Ministry of Health.

Common Steps

Final Steps for All Trial Types

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.

~1 week

Import Permit

Last step is to obtain an import permit. This will take another 1 week.

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

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

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