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Profile
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Delegates :
Takao Kawasaki |
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Incorporated :
December 24 , 1980 |
Paid in Capital :
99 Million yen |
Employees :
160 人 |
Address :
Nishi2-32, Kita2, Chuo-ku, Sapporo, Hokkaido HOKKAIDO
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TEL/FAX :
+81-11-207-7001 / 81-11-207-7177 |
URL：
http://www.oiken.co.jp |
Attachment :
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Mission/Background :
Our company began the businessin 1980. The company's name was changed to Institute of Applied Medicine, Inc. in 1997 so as to specialize in "quality evaluation testing" and "pharmacokinetics" services which are our current businesses. IAM has been being developed as a company trusted by customers under our management principle, "IAM strives to contribute to the health and social development of the public by providing analytical chemical services in our role as a good partner to pharmaceutical companies. |
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Technology & Business
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Institute of Applied Medicine, Inc. (IAM) is a contract research organization which analyzes pharmaceutical substances and/or products. As a good partner of pharmaceutical companies, IAM provide various services on analytical research, and contribute to the health of people and the development of society. IAM undertake the quality analysis of R&D and commercial products. IAM will provide a high-quality data and reports speedily. IAM have the many experiences by which IAM conducted stability testing, quality testing (shipment test under GMP) and analytical method validation of biopharmaceutical (an antibody, biotechnological peptide and protein) for approval application of JP, USA and EU. IAM possess the business results concerning the quality analysis on the pharmaceutical products (Knowhow accumulates abundantly) for 18 years, and support global development (cGMP). IAM have the both technical skills of the physicochemical analysis and the microbiological studies.
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Products & Service
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Products & Service Name
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Stage
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Outline
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Milestone
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Quality tests
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Service/Marketing
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Quality analysis of API s and pharmaceuticals containing biopharmaceuticals
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Contract of quality analysis of biopharmaceuticals
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Stability test
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Service/Marketing
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Stability tests of API and pharmaceuticals
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Contract of stability tests of API and pharmaceuticals
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Analysis of drug concentration
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Service/Marketing
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Bio-analysis of drug concentraion in biomaterials
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Contract of bio-analysis of drug concentration
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Highlights
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Our company is a contract laboratory, and CMC-related quality tests for biopharmaceuticals have implemented in drug development. Company is doing the tests in accordance with various regulations by effectively using knowhow for 18 years, and using GMP and GLP acceptable facilities. Pharmacologically active substance, substance hated the humidity and biopharmaceuticals have been tested utilizing physicochemical, microbiological and biochemical techniques
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Hot news
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1) The facilities and equipment that require temperature control which is connected to a private electric generator. 2) Response to 21 CFR Part11 raw data (electronic records) is being continued.
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Alliance strategy
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Pharmaceuticals (low molecular products synthesized chemically, biological products, biosimilars) in the R&D and manufacturing, we are involved in quality assurance of analytical services for investigational drug (stability testing, release test, analytical method validation, quality data for the application) and commercial products (release test)) to hope that alliances with companies that need analytical services for quality assurance.
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