Lot Release Testing
All products entering domestic or global pharmaceutical markets require GMP testing to ensure that they are released in accordance with approved specifications. Release testing packages are composed of a range of studies previously validated to demonstrate compliance of the product.
We provide product release for the European Union, United States and other distinct regulatory markets. We provide a full range of support, including analysis using suitable in vivo and in vitro potency assays, microbiology tests, pyrogen and monocyte activation testing (MAT) to determine purity, identity and other biochemical characteristics.
drug product release learn more
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pyrogenicity, endotoxin and monocyte activation testing learn more
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microbiology testing learn more
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