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.)