Oral Solid Dose Regulatory Hurdles And How To Approach Them

By Gillian Miller and Beth Kendsersky, Pfizer CentreOne

In your quest to meet the regulatory requirements for your oral solids project you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. Experts in the Pfizer CentreOne global network, Gillian Miller, Process Analytical Technology and Data Analytics Lead and Beth Kendsersky, Global Regulatory Chemistry, Manufacturing and Controls (CMC) Lead discuss common regulatory challenges and how to approach them.