Services related to Regulatory Support (MIAP)

• Expanded Access to Investigational Products

  MICHR’s expanded access support provides assistance for physicians throughout the process of requesting single patient expanded access.

• IND/IDE Sponsor-Investigator Training

  This training provides information on the Sponsor-Investigator requirements of an IND or IDE and resources to assist in order to be in compliance. 

• IND/IDE Lifecycle Maintenance

  The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support for all submissions that may be required by an active IND or IDE.

• IND/IDE Application Preparation & Submission

  The MICHR IND/IDE Investigator Assistance Program (MIAP) provides support and expertise to prepare and submit Investigational New Drug and Investigational Device Exemption applications to the FDA.

• IND/IDE Consultation & Development

  The MICHR IND/IDE Investigator Assistance Program (MIAP) provides consultation on research involving investigational agents (drugs, devices, and biologics).