Auxochromofours Solutions Private Limited Extractables & Leachables (E&L) Risk Assessment for Packaging Materials: Ensuring Safety and Compliance In the pharmaceutical and medical device industries, ensuring product safety and regulatory compliance is paramount. One critical aspect of this process is the Extractables & Leachables (E&L) Risk Ass...
Auxochromofours Solutions Private Limited A Comprehensive Guide to Genotoxic Impurity Assessment Under ICH M7 Guidelines - Ensuring Patient Safety In pharmaceutical development, controlling genotoxic impurities (GTIs) is a crucial step to ensure patient safety. These impurities have the potential to damage DNA even at trace levels, which increas...
Auxochromofours Solutions Private Limited Ensuring Patient Safety and Regulatory Compliance: The Importance of ISO 10993-17 in Medical Device Toxicological Risk Assessment Medical devices are at the heart of modern healthcare, saving lives and improving patient outcomes. However, their safety goes beyond performance—it’s about understanding their potential impact on pat...
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