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Implements a multi-step action plan to ensure regulatory alignment with the latest NDSRI guidelines.
December 1, 2025
By: Charlie Sternberg
Associate Editor
Piramal Pharma Solutions, a global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., has achieved regulatory compliance for nitrosamine impurities by implementing a multi-step action plan to ensure regulatory alignment with the latest NDSRI guidelines. The first step of this proactive approach involved the development of a cross-functional core team comprised of subject matter experts from Regulatory Affairs, Central Quality, R&D, and Manufacturin...
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