As oral solid dose (OSD) drugs in development become more potent, regulatory expectations keep changing. To sustain compliance proactively, drug developers and their partners must develop a clear understanding to navigate current complex regulatory environments and build their manufacturing strategies accordingly.
Otherwise, you or your manufacturing partners might be at risk, blindsided during a facility inspection with a finding that not only will slow your drug’s pace to market, but jeopardize its regulatory approval altogether.
Thomas Wilson, Contract Manufactuing Lead at Pfizer CentreOne, partnered with Pharma Manufacturing to discuss topics from regulatory models for manufacturing, the similarities and differences between the traditional and health-based models, as well as Pfizers approach to manufacturing highly potent oral solid dosage forms.
