Regulatory Affairs
Expert regulatory guidance for clinical trials — from ethics committee submissions to Ministry of Health approvals.
Turkey's regulatory authority has established clinical trial guidelines emphasizing safety and effectiveness. Our team of clinical and regulatory professionals provides expert advice on GCP compliance, documentation, and submissions applicable in Türkiye. We manage the complete regulatory process including Ethics Committee applications, Turkish Regulatory Authority submissions, amendments, and ongoing compliance management.
Key Capabilities
Ethics Committee application preparation
Ministry of Health submissions
Protocol amendments management
Safety reporting and pharmacovigilance
Ongoing regulatory compliance
Regulatory strategy development