Regulatory and Ethics Approvals
We provide full support throughout the regulatory and ethics committee approval process, ensuring clinical studies adhere to all legal and ethical standards. From strategic planning to document preparation and submission, we streamline approvals for successful study initiation.
- Regulatory strategy and planning
Our customized regulatory strategies tailored to each study’s specific needs, offering expert guidance on navigating the regulatory landscape, ensuring efficient planning and compliance with local and international regulations.
- Document preparation for study submission
Our team prepares complete and accurate submission packages, including study protocols, informed consent forms, and investigator brochures. We ensure that every document meets the rigorous standards required for regulatory and ethical approval.
- Study submission to Local Ethics Committees
We manage the entire submission procedure to local ethics committees, ensuring compliance with regional guidelines. Our thorough preparation helps reduce delays and facilitates faster approvals.
- Study submission to Competent Authorities and Central Ethics Committees
We handle submissions to national regulatory authorities and central ethics committees, ensuring that all documentation is complete and meets the specific requirements. Our expertise ensures smooth communication and timely review.