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Mitsubishi Chemical Research Corporation (MCR)

Table of Contents
Table of Contents

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.

Features of MCR’s Contract Non-clinical Study Services

Flexible capabilities backed by GLP-compliant facilities and decades of experience

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.

End-to-end regulatory support: from compliance to risk assessment and submissions

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.

Strong track record with government and public agencies

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.

Examples of Pathological and Ecological Models Available at MCR

Ecological impact test models using algae, Daphnia magna, and fish

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/

Non-clinical Study Examples Available at MCR

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

Company Information

Address5F Yotsuya TN Building, 16-1 Samoncho, Shinjuku-ku, Tokyo
Tel03-6893-6410
Websitehttps://www.mitsubishichem-res.co.jp/
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
  • SMC Laboratories, Inc. has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
  • From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.

  • With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc.
(Labcorp Drug Development)
Labcorp Holdings Inc.
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
  • Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
  • The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
  • Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
  • PhoenixBio Co., Ltd.offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
  • With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.

  • The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.

By region
list of animal models
Expertise & Track Record
3 Recommended Contract Non-Clinical Testing Services