Ethical Submissions and Regulatory Management

We have many years experience of handling regulatory and ethics committee submissions. We can provide you the following services:

  • Document preparation for study submission for Ethics Committees and Regulatory Authorities
  • Contract and budget negotiation between the investigational site and sponsor
  • Review of informed consent forms
  • Initial study submission and all updates
  • Clarification of regulatory requirements
  • Obtaining approvals from Ethics Committees and Regulatory Authorities
  • Support given to investigational sites for their local submissions
  • Communication with Ethics Committees and Regulatory Authorities throughout the trial
  • Periodic reporting required by Ethics Committees and regulatory authorities on trial status and safety information