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Regulatory Affairs
Through deep knowledge of local regulations in a continuously evolving environment that allows narrow time margins, demands constant changes, quick decisions and minimal space for errors, we are prepared to provide advice in all stages of the studies.
Execution of regulatory submissions to local IRBs/IECs
Execution of regulatory submissions to local regulatory agency
Regulatory follow-up during study, aiming at fulfilling timely reports
Timely execution of approvals and re-approvals
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