Regulatory Affairs
Expert regulatory guidance for clinical trials, from ethics committee submissions to Ministry of Health (TİTCK) approvals.
Turkey's regulatory authority has established guidelines for clinical trials that emphasize safety and effectiveness. Our team of clinical and regulatory professionals offers expert advice on Good Clinical Practice (GCP) compliance, documentation, and submissions that are relevant in Türkiye. We manage the entire regulatory process, including applications to Ethics Committees, submissions to the Turkish Regulatory Authority (TİTCK), amendments, and ongoing compliance management.
Key Capabilities
Ethics Committee application preparation
Ministry of Health (TİTCK) submissions
Protocol amendments management
Safety reporting and pharmacovigilance
Ongoing regulatory compliance
Regulatory strategy development