ATRC Aurigon Toxicological Research Center ATRC Aurigon Toxicological Research Center   Ltd. is a full-service   non-clinical CRO   with offices in   Munich ,   Germany and  GLP/GMP  sites in   Budapest ,   Hungary. Our company provides   in-life   and   bioanalytical   services for the life science industry most notably to pharmaceutical companies. We offer various types of in vivo and in vitro studies including, but not limited to   PK/PD ,  ADME ,   toxicology   and   safety pharmacology   in several species   from mouse to sheep . The studies are performed by   highly qualified staff with up to   30 years of experience   in purpose-built facilities and with the use of modern equipment and instruments.    Our most fundamental advantage – beyond our expertise – is our attitude: we provide tailor?made studies optimized for your goals  in order to maximize our added value to your project. A brief overview of our comprehensive range of services:   Wide range of pharmaceutical / healthcare categories New Chemical Entities ( NCE ) Generics Herbal Medicinal  Products Food  / Food Ingredients New Biological Entities ( NBE ) Biosimilars  / Biobetters Vaccines  / Immunotherapies Cell-Based Therapies ( ATMPs ) Medical Devices Bioanalytics Quick   method development / method transfer   for   small molecules, peptides, proteins   (including antibodies) Most  appropriate techniques  (LC-MS/MS, HPLC-UV, ELISA, Triple quad, Ion-trap, Flow-cytometry, Luminex, FACS, RIA, Radiometry: 14C, 3H, 125I, 32P, liquid scintillation and ?-counters, TopCount and online LC radioactivity detectors) Method validation   according to latest FDA, EMA and ICH guidelines Stability testing   in formulation and different matrices Bioanalytical support of   both clinical and non-clinical studies ADME/PK Pharmacokinetic and bioavailability studies  in rodents, non-rodents  and humans Tissue-distribution, protein-binding   and  excretion balance  studies Toxicokinetics  in toxicity and safety pharmacology studies In vitro  and  in vivo   metabolism studies  with profiling and  metabolite identification Biopharmaceutical  assessment (pre-formulation and formulation studies) PK, TK and  statistical evaluation   with acknowledged and validated tools First-in-man dose  prediction Dosimetry calculation  for human metabolism study Preclinical Safety and Toxicology Identification of the  Most Human-Like Species      I n Vitro  Metabolism       Tissue Cross-Reactivity ( TCR ) General Toxicity       Genotoxicity  ( in vitro  and  in vivo )       Single-Dose  Toxicity / Dose-Range Finding  (DRF)       Repeated Dose  Toxicity       Safety Pharmacology Particular Toxicity  Testing       Immunotoxicity       Hepatotoxicity       Phototoxicity       Local Tolerance  and Irritation       Reproductive  Toxicity       Juvenile  Studies       Carcinogenici ty       Drug-Drug Interaction ( DDI )       Impurities  Testing