Mitsubishi Chemical Research Corporation (MCR) provides non-clinical studies in their own GLP-compliant facilities. Leveraging its extensive experience and specialized expertise, MCR supports the safety evaluation of chemical substances as well as supports for compliance with regulatory requirements in foreign countries.
MCR operates their own GLP-compliant facilities and offers an integrated range of regulatory submission studies that meet domestic and international requirements. With long-standing expertise, the company provides tailored study proposals based on the properties and intended applications of test substances.
Their capabilities include biodegradability studies, bioaccumulation studies, ecological impact testing, and polymer-related testing. In addition to in-house studies, certain testing can be conducted in collaboration with external specialized institutions. Monitoring and quality oversight are also available.
MCR provides comprehensive support for registration applications under various chemical regulatory standards, including Japan’s Chemical Substances Control Law and Industrial Safety and Health Act, the U.S. TSCA, and the EU REACH regulation. Through close cooperation with local representatives, MCR assists with the planning of efficient submission strategies and communication with regulatory authorities.
The company has gained recognition as a highly trusted partner for regulatory compliances. They offer support for GHS classification, SDS preparation, risk assessment, and voluntary environmental management such as wastewater management.
A defining strength of MCR is its extensive record of projects commissioned by Japanese government agencies such as the Ministry of Economy, Trade and Industry, the Ministry of the Environment, the Japan Patent Office, and the Ministry of Agriculture, Forestry and Fisheries. MCR has demonstrated high-level expertise across a broad industries, including chemical substance safety assessment, risk evaluation, and technology trend analysis.
They have contracted numerous public research projects with their specialty, reliability and flexibility.
As part of their ecological impact assessment services, MCR provides models with algae, Daphnia magna, and fish. These models are suitable for evaluating the environmental effects of pesticides and chemical products on aquatic ecosystems and play an essential role in environmental risk assessment.
Comprehensive study designs can be incorporated with biodegradability and bioaccumulation tests, enabling compliance with regulatory requirements in various countries. High-quality, GLP-compliant data can be generated for test substances across various development stages—from early stage to clinical submission.
Reference: MCR official website https://www.mitsubishichem-res.co.jp/psa/
MCR provides a wide variety of non-clinical studies, including genotoxicity testing (Ames test, chromosomal aberration test, micronucleus test), acute and repeated-dose toxicity studies, and skin irritation and sensitization studies.
For human health impact assessments, they can support the evaluation of special substances, such as reaction products and gas state material. GLP-compliant studies can be accommodated with highly reliable domestic and international partnered institutions.
They offer tailored study proposals, including CSR-related activity, in compliance with the MARPOL Convention, and environmental risk assessment of pharmaceutical drugs.
Reference: MCR official website https://www.mitsubishichem-res.co.jp/psa/hht_test.html
| Address | 5F Yotsuya TN Building, 16-1 Samoncho, Shinjuku-ku, Tokyo |
|---|---|
| Tel | 03-6893-6410 |
| Website | https://www.mitsubishichem-res.co.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.