Japan Food Research Laboratories (JFRL) conducts a wide range of non-clinical studies on pharmaceutical drugs, medical devices, and chemical substances in compliance with the GLP standard.
With extensive experience and comprehensive testing facilities, the organization provides contract research services covering safety and toxicity evaluations, as well as storage stability testing, to meet diverse clients’ needs.
JFRL performs both in vitro and in vivo studies in compliance to GLP standards. Its capabilities include various toxicity evaluations—such as cytotoxicity, mutagenicity, and acute toxicity testing for medical devices, pharmaceutical drugs, and chemical substances. Analytical methods followed by ISO, OECD Test Guidelines, and the Japanese Pharmacopoeia, ensuring full regulatory compliance.
The laboratory also provides flexible study designs tailored to client’s requirements and applicable legal frameworks.
A notable strength of JFRL is its capability to conduct testing across a broad spectrum of materials and products, such as medical devices and their components, foods, pharmaceutical raw materials, and industrial chemicals. By applying multiple international and domestic standards—such as OECD TGs, Medical Device Guidance, and the Japanese Pharmacopoeia—JFRL offers customized testing strategies suited to the intended use and characteristics of each material.
Each test category clearly specifies its applicable scope and required sample quantities, allowing for efficient study planning from the beginning.
For storage stability studies, JFRL operates their specialized facilities equipped to perform long-term, accelerated, and stress-condition testing. The facilities are supported by an independent power supply and automated alert systems, ensuring prompt responses to any unusual event during the testing period.
Temperature, humidity, and light conditions can be precisely controlled to accommodate diverse storage requirements, with its integrated analytical systems in place for post-storage evaluation. This robust infrastructure enables JFRL to meet a wide range of stability assessment needs.
No information on disease models was found on the official website.
JFRL conducts reversion mutation tests (Ames tests) for medical devices, chemical substances, and food products.Mutagenicity is assessed following the 1999 Ministry of Health, Labour and Welfare guidelines and medical device guidance.
Tests are typically conducted using 5 g of solid samples or 10 g of liquid samples, with a standard turnaround time of approximately two months. The cost starts from 400,000 yen (excluding tax), and expedited testing is not available. This study design is particularly relevant to applications in the pharmaceutical and chemical sectors.
Reference: https://www.jfrl.or.jp/service/safetytrial
| Address | 52-1 Moto Yoyogi-cho, Shibuya-ku, Tokyo, Japan |
|---|---|
| Tel | 03-3469-7131 |
| Website | https://www.jfrl.or.jp/ |
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.