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FDA’s 2025 warning letters are out — and they send a very clear message: the agency is back in force on GMP enforcement, and the fundamentals are where firms continue to stumble. Whether your operations are sterile or non-sterile, API or finished dose, the issues that keep showing up are not random — they point […]
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Suspected Unexpected Serious Adverse Reactions (SUSARs) represent one of the highest regulatory risk areas in clinical development. Health Authorities (HAs) globally, including the FDA, EMA, and national competent authorities, impose strict timelines and documentation expectations for SUSAR identification, assessment, and reporting. Sponsors frequently delegate pharmacovigilance (PV) case processing and regulatory reporting activities to Contract Research […]
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