US FDA regulatory support

All federal agencies and departments in the US have their own rules and regulations for conducting human research, which must be adopted. If a new drug/device or an approved drug/device is to be administered for a new indication, then the test must be conducted in accordance with the US FDA rules and regulations.

The FDA’s mission is to ensure that clinical research is designed, conducted, and reviewed according to federal law and GCP, producing credible evidence of safety and efficacy. By partnering with experienced regulatory experts, sponsors can accelerate development, minimize regulatory risks, and achieve successful approvals.