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Starting October 1, branded pharmaceuticals imported into the U.S. will face a 100 % tariff. Generics are excluded — at...
In highly regulated industries, audits are or should not be just a compliance checkbox — they are a cornerstone of...
Historically, Quality Compliance has been seen as a box to check before an inspection, with the scope of passing it....
In biomanufacturing, digital twins are gaining traction to help manufacturers simulate, monitor, and optimize processes. And as regulators signal increasing...
What GMP Annex 22 Means for Pharma Artificial Intelligence (AI) is moving from pilot projects to real-world pharmaceutical manufacturing applications—but...
The European Medicines Agency (EMA) recently released its 2024 Annual Report, offering a comprehensive overview of regulatory achievements, innovation drivers,...