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Category: Regulatory

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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Preparing for DSCSA Track and Trace Implementation
Counterfeit drugs have become big business. In 2019, it was estimated that $200 billion worth of counterfeit...
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Patent Cliff 2.0: How to Leverage the 351(k) Pathway for Biosimilars
More than $198 billion in global prescription drug sales are at risk from patent expirations between...
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Analytical Testing for Drug Development
How do you ensure that your active pharmaceutical ingredients, their starting materials and intermediates,...
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