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The high-stakes nature of nitrosamine impurities in APIs
The presence of nitrosamines in drug products on the market can trigger recalls, causing severe financial and reputational damage. Moreover, during the approval process of a new drug, insufficient data on nitrosamines can lead to costly delays. Download Solvias’ white paper for insights into navigating nitrosamine risks and ensuring compliance with regulations.
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FDA insights
Enhance your understanding of critical factors influencing regulatory outcomes.
Challenges in nitrosamine testing
Learn how the right expertise and equipment are paramount for risk identification.
Risk mitigation
Discover strategies to mitigate nitrosamine-related regulatory risks and expedite drug approval processes.