Inspection Readiness & Support
Strategy and planning around inspection readiness can often be challenging to balance with the many considerations during study execution. Our TMF Inspection Readiness Workshops provide you with the tactical guidance necessary to successfully navigate regulatory inspections. Our team has proven experience with FDA, EMA, MHRA, PDMA, and others, resulting in approvals.
- Inspection Readiness and Preparation Workshops
- Needs Assessment Workshop
- Sponsor Oversight Requirements Workshop
- eTMF Requirements Workshop
- Inspection Support