Comprehensive training, organizational contacts, and meticulous hosting protocols for FDA inspections
Offering Category: Does your study involve an investigational drug or device?
A course introducing the regulatory responsibilities of sponsors and investigators in drug and device studies
Details U-M Research Pharmacy’s standards for investigational drugs and approved exceptions with rigorous protocols to maintain the utmost safety and regulatory integrity in your clinical trials
Guide to optimize clinical trial oversight with vigilant protocol adherence and compliance, prepared for any sponsor, university, or regulatory audits
Independent monitoring for IND/IDE investigator-initiated clinical trials
Guidance in assessing if you need an investigational new drug (IND) or investigational device exemption (IDE) for your study
Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) pre-submission meeting requests to the FDA
Support and expertise to prepare and submit investigational new drug (IND) and investigational device exemption (IDE) applications to the FDA
Support for all submissions to the FDA for sponsor-investigated studies conducted under an investigational new device (IND) or investigational device exemption (IDE)
Expert consultation for researchers on FDA regulatory requirements and compliance for studies involving investigational drugs, devices, and biologics