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Category: Regulatory

Final Deadline: Completing DSCSA Track & Trace Implementation Before November 2023
As we discussed last September, counterfeit drugs are not only big business, but they also pose a significant...
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Best Practices for Successful Method Validation
When method validation is performed incorrectly, companies pay a price in multiple ways. Inaccurate method...
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What You Need to Know About Post-Approval Change Pathways
Post-approval changes (PACs) – changes made to the drug substance manufacturing process after receiving...
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Quality, Clarity and Speed: An Integrated R&D and Regulatory Approach
With cost containment a priority and supply chain disruptions a now-persistent threat, pharmaceutical...
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Ensuring OTC Quality: Drug Formulation Isn’t Just for Prescription Medications Anymore
Quality systems for prescription medicines are – by necessity – extremely robust. Ensuring compliance...
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Top Pharmaceutical Manufacturing Quality Challenges
To pharmaceutical manufacturers, it may seem that quality has always been a key pillar of pharmaceutical...
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