Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them ...
Jaenisch, Muraru, and Pandey discuss how regulators will audit pharma against its own AI policies and ways QA and regulatory ...
CDMOs announced expansions, exhibitors showcased automated equipment, and supply chain strategy discussions were a focus at ...
USP’s Sheehan and Liu talk at AAPS PharmSci 360 abou getting novel excipients past the monograph hurdle through early engagement with FDA.