Manufacturing site transfers

Every technology transfer has to be analyzed and planned from scratch, assessing the best way to carry it out while minimizing risks.

The manufacturing site transfer is not the end goal, but the path to manufacturing the pharmaceutical product in a different plant. Therefore it is necessary to know the regulatory implications of the transfer activities.

iReg consulting is well experienced with such projects and provides the following services to our clients

Third-party manufacturer’s coordination; data collection and verification
Regulatory intelligence services
Conduct CMC gap analysis to assess current process understanding, gaps, and remediation plan
Determine tech transfer strategy for each product with measures for success and risk analysis
Compilation of variation applications