Contract Research
Overview
FDSC offers contract research services for safety and quality testing of compounds, materials, foods, drugs, medical devices and chemical agents. Preclinical and laboratory studies on safety testing are available under GLP standards and non-GLP requirements. Biological tests of product quality are available under GMP. Our experience on the global level provides you with the ability to adapt to not only domestic, but also international standards of safety evaluation. For drugs and chemicals, FDSC can offer a variety of tests for "Safety" and the specification tests required of a product for "Quality". For medical devices, the safety evaluation can be done through a selection of test methods and extraction of test samples in accordance to the testing standards and practices of ISO10993, FDA and ASTM.
Specialty
FDSC can also accommodate special projects with our highly qualified, expert scientific research staff. We are equipped to accommodate genotoxicity tests and in vitro tests as an alternative to animal testing. The local lymph node assay (LLNA), to assess chemical sensitization, the tumorigenicity test in athymic nude mice, and pathological examinations, and electron microscopy-autoradiography, are available.
Safety tests
General toxicity
●Single-dose, repeated-dose and chronic toxicities
Immunotoxicity
●Allergenicity
Antigenicity, Skin sensitization, LLNA
Genotoxicity
●DNA damage
DNA-adduct formation
●Gene mutation
Bacterial cell mutation: Ames test
●Chromosomal aberration
Chromosomal aberration of cultured cells, in vitro micronucleus test, in vivo micronucleus test
Cytotoxicity
●Inhibition of colony formation
Direct contact-, tissue culture insert- and subconfluent- and indirect contact(agar overlay)-tests
●Neutral Red test
Photocytotoxicity
Local irritation testings for medical devices
●Irritation tests for eyes, oral-, vaginal-, penile- and rectal-mucosa, and skin
●Intradermal test, implantation test, hemocompatibility test
●Biological safety test of contact lenses
Specification tests of product quality:
based on Japanese GMP standards
●Animal tests:
Abnormal toxicity, pyrogen test, histamine test
●Cytotoxicity test
Proficiency Testing for Food Hygiene
Proficiency testing in analytical chemistry and microbiology, part of the external quality control for food hygiene, contributes to the quality assurance of the results of tests conducted at Japanese food testing laboratories.
Supply of Reference Materials
Reference materials for cytotoxicity and implantation tests of medical devices.
Positive and negative control specimens for the cell toxicity tests and implantation tests are supplied at cost, as required for domestic or international orders.
These Reference Materials have been used for tests according to Japanese Guidelines and ISO10993.
