We provide high-quality data obtained from a quality assurance process evaluated by the U.S. FDA (cGMP)!
Our company uses a quality assurance process evaluated by the U.S. FDA (cGMP) to analyze and evaluate the quality of pharmaceuticals and similar products from the research and development stage to the commercial manufacturing stage using physicochemical methods, biochemical methods, and microbiological methods. We have extensive experience in responding to inspections and investigations by regulatory authorities and global quality assurance departments, with a proven track record in various GMP shipping tests and approval application tests, including physicochemical tests, microbiological tests, and biochemical tests of biopharmaceuticals. [Features] ■ Abundant experience and accumulated know-how *For more details, please download the PDF or contact us.
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【Service Content】 ■ Supports not only low molecular weight pharmaceuticals but also biopharmaceuticals (medium and high molecular weight), narcotics, psychotropic drugs, and active pharmaceutical ingredients and formulations of highly pharmacologically active substances. ■ Main Equipment and Facilities - General-purpose equipment such as HPLC, UPLC, and GC - Plate readers compatible with detection systems - Stability testing equipment, facilities for microbiological testing, cell culture laboratories, etc. ■ Testing of Highly Pharmacologically Active Substances - A chemical hazard room is established, capable of handling highly pharmacologically active substances. *For more details, please download the PDF or contact us.
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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.