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Tag: regulatory

Best Practices for Successful Method Validation

August 01, 2023

When method validation is performed incorrectly, companies pay a price in multiple ways. Inaccurate method...

What You Need to Know About Post-Approval Change Pathways

April 01, 2023

Post-approval changes (PACs) – changes made to the drug substance manufacturing process after receiving...

Quality, Clarity and Speed: An Integrated R&D and Regulatory Approach

March 03, 2023

With cost containment a priority and supply chain disruptions a now-persistent threat, pharmaceutical...

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