Regulatory Approvals and Support
Optimus Clinical Research offers expert regulatory support to navigate the complexities of clinical trials. From preparing and submitting documents to health authorities and ethics committees to ensuring compliance with evolving local and international regulations, we streamline the approval process. Our ongoing support and expertise ensure trials meet all regulatory expectations seamlessly.
Regulatory Submission
- Assist in the preparation of regulatory documents for submission to health authorities (DRAP, NBC)
- Handle ethics committee/institutional review board submissions and track approvals.
Regulatory Compliance Monitoring
- Ensure compliance with local, national, and international regulatory requirements.
- Provide ongoing support to meet regulatory expectations throughout the trial lifecycle.
- Assist in addressing regulatory queries and audit requests.
Regulatory Navigation
- Maintain up-to-date knowledge of evolving regulations to ensure continuous compliance.