Regulatory Support

Regulatory Support provides the following services:

• Consultation in regards to IND/IDE requirements
• Consultation in regards to IND exemption
• Consultation for Sponsor-Investigators
• IND/IDE submission support
• Maintenance and regulatory support for INDs/IDEs
• Standard Operating Procedures (SOPs) – Guidance, review, evaluation, etc.
• Assistance with interpretation and implementation of guidelines (FDA guidance documents, ICH-GCP, etc.)
• Assistance with research specific forms: AE logs, con-med logs, delegation of authority logs, etc.
• Project management
• Collaborate with UM CTSI’s regulatory support initiatives
• Investigational New Drug (IND)/ Investigational Device Exemption (IDE) consultation for Sponsor-Investigators
• IND/IDE submission support
• Maintenance and regulatory support for INDs/IDEs
• Assistance with interpretation and implementation of regulations and guidelines (FDA CFR, guidance documents, ICH-GCP, etc.)