IND/IDE Support

Managing IND/IDE Submissions to the FDA

The IND/IDE regulatory specialists provide guidance to sponsor-investigators regarding the process of submitting an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA in order to collect safety and effectiveness data for human subject clinical trials.

Our senior regulatory specialists provide guidance, support, and management of FDA requirements for IND/IDE applications, including:

• Review initial protocol to identify readiness for FDA submission
• Coordinate and schedule pre-IND and pre-submission meetings with the FDA
• Prepare and submit IND/IDE applications and reports
• Compile initial and amended protocols, investigational drug or device information