An US-based leading global pharmaceutical company was in need of trial master file (TMF) gap analysis and tool deployment. Having complex TMF landscape with multiple CROs and several TMF repositories, the client’s requirement for CAPA resolution and eTMF deployment was a challenge to address. In addition, there were critical Regulatory authority findings.

Read through this case study for insights on how successful Freyr was in closing critical findings of competent authorities by offering CAPA resolution and eTMF deployment.