Non-clinical trial project
As a contract research facility compliant with various GLP standards and accredited by AAALAC, we conduct safety and efficacy evaluation tests for pharmaceuticals, medical devices, regenerative medicine products, and more.
Our company conducts safety and efficacy evaluation tests for pharmaceuticals, medical devices, regenerative medicine products, cosmetics, health foods, pesticides, and chemical substances using various animals under GLP compliance, including bacteria and cells. Additionally, as an AAALAC fully accredited facility, we ensure comprehensive consideration for animal welfare. 【Non-Clinical Testing Business Content】 ■ Safety Testing Safety testing for pharmaceuticals, medical devices, food, and chemical substances. We have numerous laboratories and breeding facilities capable of accommodating small animals (mice, rats, guinea pigs) to medium and large animals (rabbits, monkeys, dogs, mini pigs). As an AAALAC fully accredited facility, all animal tests are conducted following international standards and committee review. The test results conducted at our facility can be used without issue for applications to overseas regulatory authorities and as academic science reports. - Toxicity testing and safety pharmacology testing - Special toxicity testing - Immunotoxicity testing - Genotoxicity testing ■ Pharmacological Testing - Cardiovascular - Respiratory ■ Support for various surgical procedures ■ Compliance with GMP shipping tests using experimental animals
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- Toxicity Testing and Safety Pharmacology Testing It is possible to incorporate safety pharmacology tests and genotoxicity tests, as well as immunotoxicity tests, into general toxicity testing. For example, cardiovascular safety pharmacology evaluations in dogs and monkeys, FOB evaluations in rats, dogs, and monkeys, and bone marrow micronucleus tests in rats. - Special Toxicity Testing Local pulmonary irritation tests via intratracheal administration can be conducted in awake guinea pigs and monkeys, and in anesthetized mice and rats. - Immunotoxicity Testing Lymphocyte subset analysis, NK cell activity, and TDAR tests using rats and monkeys will be conducted. Incorporation into general toxicity testing is also possible. - Genotoxicity Testing Initial screening can be conducted quickly and with a small amount of test substance. A second in vivo micronucleus test using young rats can also be performed. - Pharmacological Testing We are equipped with various measurement devices, including clinical polygraph systems, and ion channel measurement systems using cells, enabling accurate and detailed cardiovascular evaluations compliant with GLP. In particular, echocardiography allows for non-invasive cardiovascular assessments, minimizing stress on animals, and can be used for repeated evaluations in safety testing. *For more details, please feel free to contact us.*
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【Purpose】 ■Non-clinical trials *For more details, please refer to the PDF document or feel free to contact us.
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CMIC Pharma Science Co., Ltd. CMIC Bioreseach Center, Kobe Laboratory, Sapporo Laboratory
Our company, as a Non-Clinical CRO, provides solutions in the non-clinical field throughout the entire product lifecycle, from research and development stages to commercial stages, including preclinical research, bioanalysis, CMC quality analysis, analysis/measurement of biopharmaceuticals across these areas, consulting, medical writing, and more for pharmaceuticals and medical devices. In close collaboration with our group companies, we fully support our customers' value chain from product development to manufacturing, sales, and marketing across the US, Europe, and Asia. Please feel free to contact us if you have any inquiries.