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Eurofins BioPharma Product Testing Japan

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Eurofins BioPharma Product Testing Kyoto

93, Awata-cho, Chudoji
Shimogyo-ku, Kyoto, 600-8815
JAPAN

Email: easl-cserv@eurofins.com
Website: https://www.eurofins.co.jp/eurofins-biopharma-product-testing-kyoto

Equipment List

Eurofins Analytical Science Laboratories

Originally established as a subsidiary of Fujisawa Pharma in 1996, Eurofins BioPharma Product Testing Kyoto joined the Eurofins Group via Astellas Pharma in November 2018. Eurofins BioPharma Product Testing Kyoto is the Japanese base of the pharmaceutical analytical division (BioPharma Product Testing) in Eurofins and provides solutions for various analytical testing in the drug development process from new drug development to commercial manufacturing.

Eurofins BioPharma Product Testing Kyoto has more than 20 years of GMP experience in conducting analytical studies in compliance with global regulations in USA, EU and Japan and supports method development, method validation, release testing and stability studies for both pharmaceuticals and biopharmaceuticals. In particular, we have vast experience with method development for metal identification and microbial testing.

Eurofins BioPharma Product Testing Kyoto also provides formulation development support and foreign matter analysis through advanced expert analysis, such as nondestructive and surface analyses. If a raw material or drug substance/product is found to be contaminated with a foreign matter, it is required to identify the contaminant as soon as possible. Eurofins BioPharma Product Testing Kyoto can satisfy customers not only by providing prompt results, but also by presuming the source of the contamination based on our previous experiences in dealing with micro-foreign matters.

Reference standards for drug substances, intermediates and related substances are very important in pharmaceutical analyses. Eurofins BioPharma Product Testing Kyoto also provides comprehensive services including storage, quality testing and shipment to manufacturing sites or laboratories.

Accreditations/Certifications/Registrations:

  • GMP compliant
  • FDA audited
  • PMDA audited