Regulatory Affairs

ANTAEA Regulatory Affairs Department offers its multinational expertise in compliance with the diverse Local Regulatory Agencies and Health Authorities concerning the conduct of your Clinical Trials.
Our long-lasting relationships established between the Group and the Regulatory Agency Representatives facilitate communication and save your time.
Services performed by our Group include, but are not limited to:

• Local Ethics Committee and Hospital Scientific Council submissions
• Central Ethics Committee submissions
• Regulatory Authority submissions
• Investigational Product import permit applications
• Local medication depot engagement if applicable
• Submission of Amendments
• Notifications to Central Ethics Committees, Local Ethics Committees, Hospital Scientific Councils, and Regulatory Authorities
• Safety Reporting
• Submissions of Progress reports and Final reports to IRBs and Regulatory Authorities
• Facilitation or representation for local Insurance as needed