EC/MOH Submission
MEDIKAPOLI CRO provides comprehensive support for Ethics Committee (EC) and Ministry of Health (MOH) submissions, ensuring that all regulatory requirements are fully met for timely study approval. Our experienced regulatory team manages the complete submission process, from document preparation and review to final submission and authority communication.
We ensure that all study documents, including protocols, PIS/ICF, investigator documents, and essential regulatory files, are accurately prepared and aligned with local regulations and ICH-GCP standards. Our team maintains close coordination with Ethics Committees and Health Authorities, promptly addressing queries and managing required revisions to facilitate smooth and efficient approvals.
With our regulatory expertise and structured approach, we help minimize delays, reduce administrative burden, and support the successful initiation of clinical research projects.