Nonclinical Efficacy Testing » Non-Clinical CROs and Agencies » Japan Food Research Laboratories

Japan Food Research Laboratories

Table of Contents
Table of Contents

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.

Features of JFRL’s Contract Services for Non-Clinical Studies

Comprehensive Toxicity Evaluation System In a Wide Range of Testing Methods

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.

Testing for a Wide Variety of Materials Including Medical Devices and Chemicals

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.

Specialized Facilities for Stability Testing

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.

Example of Disease Models by JFRL

No information on disease models was found on the official website.

Case Example of JFRL’s Non-Clinical Testing

Evaluation of Genotoxicity Using the Ames Test

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

Company Information

Address52-1 Moto Yoyogi-cho, Shibuya-ku, Tokyo, Japan
Tel03-3469-7131
Websitehttps://www.jfrl.or.jp/

3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise

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.

Pharmacology (Efficacy) StudiesDisease-Relevant Models for
Translational Drug Evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)

SMC Laboratories, Inc.

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.

Areas of Expertise
Disease-Relevant Model Portfolio

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 Design Based on Target Biology

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.

Support from Target Validation to Proof of Concept

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.

Safety StudiesComprehensive Safety Assessment for
Preclinical Development
Charles River Laboratories
Reference: Charles River Laboratories official website (https://www.criver.com/)

Charles River Laboratories

Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.

Areas of Expertise
General Toxicology Across Study Designs

Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.

Non-GLP and GLP Study Support

Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.

Integrated IND-Enabling Safety Assessment

Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.

Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with
Pharmacological Response
Inotiv
Reference: Inotiv official website (https://www.inotiv.com/)

Inotiv

Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.

Areas of Expertise
Pharmacokinetic Characterization

PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.

Exposure–Response Evaluation

Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.

Integrated DMPK and Development Support

Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.

By Therapeutic Area
Disease Animal Models
and Reviews
Proven Capability, Expertise and Track Record
Top 3 Non-Clinical CRO Services