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