Successful FDA inspection for Quality Assistance
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… Press release - For immediate release Donstiennes, Belgium, … product-dedicated expertise in analytical sciences. Press relations : Julie Jia Corporate Communication Manager …
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2D-LC–MS for the Analysis of Monoclonal Antibodies and Antibody–Drug Conjugates in a Regulated Environment
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… [GLP], and good clinical laboratory practice [GCLP] compliance). High-resolution MS is indeed a powerful tool … [GLP], and good clinical laboratory practice [GCLP] compliance). High-resolution MS is indeed a powerful tool …
BEBPA : EUR Bioassay Conference 2019
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… and technical excellence with a problem-solving approach compliance with all applicable EMA, FDA and ICH regulations …
BioWin Days 2025
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… Batch testing Statistical services Bioanalytical services Elemental impurities Characterisation of proteins by MS GET IN TOUCH …
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… to provide the best response to any client request in full compliance with the cGxP regulations. Moreover, Quality …
BEBPA : EUR Bioassay Conference 2018
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Partnership between Spectralys Biotech and Quality Assistance
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… methods in accordance with EMA/FDA/ICH regulations and in compliance with the highest quality standards of the …
CPhI WorldWide 2017
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… products will have to comply with the ICH Q3D guideline for elemental impurities. Although this guideline sets specifications for … approach also involves the determination of metallic impurities in APIs and excipients . As a Contract Research …