CMC analytical support

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Leveraging state-of-the-art technology and rigorous scientific methodologies, we provide a full spectrum of CMC analytical support, including: · Method Development and Validation · Cleaning Validation · Stability Testing · Dissolution Studies (including TIM1/TINY TIM gastro-intestinal model) · Orthogonal Methods Development · Impurities Identification and Isolation · Elemental Impurities Determination (ICH Q3D) · Nitrosamines Determination and Testing · Pyrrolizidine Alkaloids (PAs) Determination and Testing · Dioxins and Furans Analysis · Glycols Analysis · Extractables & Leachables Services · Microbiological Testing · Analytical Characterization · Release Testing
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Analytical Chemistry (Biopharmaceutical Services)
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Laboratory and Analytical ServicesBiopharmaceutical Services

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