Regulatory submissions are critical milestones during study start-up and the outcome has a substantial impact on the timelines and conduct of the entire clinical study. Submission requirements vary between countries and the quality of submission packages can influence approval timelines. Changes are inevitable in clinical studies and these changes may require additional submissions (i.e., amendments) before implementation can take place.
CA and EC submissions
Streamline regulatory submissions
Medicorent’s knowledge of local requirements for regulatory submissions and our focus on proactive planning and efficient communication are key to speeding up the submissions process and reducing timelines. Let us support you with your regulatory submissions during the entire clinical study period, from start-up to close-out.
Compiling submission packages
Ethics Committee (EC) submission
Competent Authority (CA) submission
Country-specific submissions (biobank, radiation committee, etc.)
Reporting in EudraCT
Interpretation of regulatory requirements
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