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Category: 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...

Ensuring OTC Quality: Drug Formulation Isn’t Just for Prescription Medications Anymore

January 01, 2023

Quality systems for prescription medicines are – by necessity – extremely robust. Ensuring compliance...

Top Pharmaceutical Manufacturing Quality Challenges

December 02, 2022

To pharmaceutical manufacturers, it may seem that quality has always been a key pillar of pharmaceutical...

Preparing for DSCSA Track and Trace Implementation

September 30, 2022

Counterfeit drugs have become big business. In 2019, it was estimated that $200 billion worth of counterfeit...

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