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Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing, and Control Post-Approval Change Pilot
Cynthia Ban, Jamie Graham, Lyne Le Palaire, Priya Persaud, Franziska Brehme, Olivier Faure, Allison Rameau and Ana Luisa Silva
PDA Journal of Pharmaceutical Science and Technology May 2025, 79 (3) 295-302; DOI: https://doi.org/10.5731/pdajpst.2024-003023.1