Multifaceted and highly variable between different countries and regions, regulatory inspections preceding product approval comprise of an intense process that can span days or weeks. In this whitepaper, Jo Beth DeFreitas, Senior Director of Quality Assurance, and Eunah Yoh, Site GMP Compliance Lead, break down how a CDMO can guide biopharmas through a successful regulatory inspection using a combination of industry and regulator knowledge as well as facility and employee preparation and flexibility. At Samsung Biologics, we optimize performance through the systematic, transparent application of best practices, integrated within the framework of audit and inspection management.
Multifaceted and highly variable between different countries and regions, regulatory inspections preceding product approval comprise of an intense process that can span days or weeks. In this whitepaper, Jo Beth DeFreitas, Senior Director of Quality Assurance, and Eunah Yoh, Site GMP Compliance Lead, break down how a CDMO can guide biopharmas through a successful regulatory inspection using a combination of industry and regulator knowledge as well as facility and employee preparation and flexibility. At Samsung Biologics, we optimize performance through the systematic, transparent application of best practices, integrated within the framework of audit and inspection management.
- CDO
- CGMP
- ADC
- Bio Campus
- IR
- CMO