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Why Pharmacopoeia Compliance Is Necessary (PDF)

Published on: September 15, 2019

J. Mark Wiggins, Joseph A. Albanese

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.

Guidance on Quality Culture Standards

FDA Approves New Moderna COVID-19 Vaccine mNEXSPIKE

A CDMO’s Role in API Quality