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Toxikon- Europe N.V.

Romeinsestraat 12

Leuven, 0 B-3001 BE

Toxikon Corporation is a life science company and a Contract Research Organization (CRO) that primarily conducts compliance studies for product safety.

Headquartered in Bedford, Massachusetts, Toxikon owns and operates a 12,500 m² state-of-the-art facility. With 30 years of industry experience, Toxikon conducts compliance safety testing and research following Good Laboratory Practices (GLP). The safety studies performed in support of United States FDA, Japanese, and other international regulatory compliance for products developed from medical devices, biotech, and pharmaceutical industries. The safety services include complete range of toxicology, acute, subchronic, and chronic toxicity, reproductive toxicity, genetic toxicology, carcinogenicity, pharmacokinetics (PK), toxicokinetics (TK), bioavailability, ADME, extensive chemical characterization, impurities analysis and synthesis, bioanalytical, and microbiology.

The European laboratories are located in Leuven, Belgium. They operate a brand new state of the art facility. Additional to the total package of services that Toxikon offers on a worldwide scale, Toxikon Europe is focusing on Extractables and Leachables testing.

Technical Information:

Pharmaceutical Testing, Medical Device Testing, Biologic Testing. FDA GLP Toxicology Testing, Pharmacokinetic Testing, PK/TK Testing, Chronic (Repeat Dose) Studies, Immunotoxicology, Reproductive/Developmental Toxicology, Carcinogenicity, Genetic Toxicology, Bioanalytical testing, Microbiology testing, Pharmacology testing, Biocompatability Testing, Cytotoxicity Testing, Sensitization Testing, Irritation/Intracutaneous Reactivity Tests, Systemic Toxicity (Acute), Toxicity (Subacute to Chronic)Implantation Tests, Genotoxicity, Hemocompatibility, USP Class VI Tests, Carcinogenicity, Immunotoxicity, Dermal Toxicology Testing, Ocular Toxicology Testing, Finished products, batch sample testing and QC samples, In process analysis, Specialty chemicals
Identification of unknown compounds, Polymer fingerprinting, Monograph testing - USP, BP, EP, JP, AOAC testing, Analytical Testing, Elemental analysis, Characterization of polymers and impurities by infrared (FTIR) spectroscopy, Degradate quantitation, Impurity Analysis, Compendial Tests (E.P, USP, J.P), Extractables/Leachables, Physicochemical Tests, Raw Material Qualification, Chemical Comparisons, Residue Analysis, ICH stability testing, Long term Stability Testing, Accelerated aging Stability Testing, Forced degradation Testing

DISCLAIMER: This Laboratory Profile was provided by the company above.