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Partnering with a leading provider of outsourced stability storage is revolutionizing the pharmaceutical and medical device industries by streamlining processes, ensuring product quality, and maintaining strict regulatory compliance across global markets.
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During an ICH stability study, a stability chamber malfunction threatened hundreds of samples and potential regulatory delays. The pharmaceutical company activated Q1 Scientific's disaster recovery plan, enabling a swift 24-hour transfer of samples in line with ICH guidelines.
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Testing for nitrosamines — potential carcinogens found in food, beverages, cosmetics, and pharmaceuticals — is essential in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug products to ensure safety and compliance.
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A healthcare manufacturer facing space constraints and regulatory pressures outsourced their stability storage needs to Q1 Scientific, resulting in reduced costs and focus on core competencies. Through this partnership, the manufacturer was able to achieve their quality goals while reducing costs and concentrating on their core competencies.
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Nitrosamine Capabilities
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Identify impurities and perform confirmatory testing under cGMP with our expert team using advanced mass spectrometry technology to enhance your drug product development. Cambrex's tailored analytical methodologies meet specific product needs and can expedite rush timelines upon request.
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