Clinical & Regulatory
When it comes to understanding clinical trials, our colleagues know how to develop clinical protocols, obtain IDE and IRB approvals, and conduct clinical studies per protocol. They can also develop regulatory submissions for the:
- FDA — Food and Drug Administration
- HHS — Health and Human Services (Medicare)
- European Union (EU) – Competent Authorities
- European Union (EU) – Notified Bodies
- State Regulatory Bodies
And obtain market clearance and approval for:
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