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