Regulatory Compliance

Essential regulatory support is provided by the IND/IDE Assistance Program in the University of Minnesota Academic Health Center. The IND/IDE Assistance staff has several decades of regulatory, clinical, quality, and development experience from the pharmaceutical and medical industries, and is directly involved at every phase of development and clinical production.

Services provided include:

• Determining the need for an IND/IDE

• Determining the contents of the IND/IDE applications

• Providing guidance and oversight of CMC (Chemistry, Manufacturing and Control) sections of INDs

• Providing education and templates to help sponsor-investigators comply with their regulatory obligations

• Providing assistance in preparing forms and communications to FDA as needed or required.