While maintaining an active TMF process within your organization can help establish a culture of inspection-readiness, inspection preparation is a distinct process that readies your...

Preparing for a regulatory inspection can be daunting – but it doesn’t have to be. The best approach to reduce the stress of an inspection...

To facilitate virtual TMF inspections and improve efficiency, the European Medicines Agency (EMA) encourages sponsors to provide inspectors direct system access to the eTMF on...