A site where you can find recommended contractors for non-clinical testing｜effical " Non-Clinical CROs and Agencies " WAKENYAKU CO.,LTD.

WAKENYAKU CO.,LTD.

Table of Contents

WAKENYAKU CO.,LTD. supports research and development across biotechnology and related disciplines. Here, we provide an overview of our nonclinical study capabilities, representative disease models, and case examples. Please use this information as a reference when selecting a CRO to conduct nonclinical studies.

Nonclinical studies undertaken by WAKENYAKU CO.,LTD.

WAKENYAKU CO.,LTD. conducts high-quality toxicology (safety), pharmacology/efficacy (PD), and pharmacokinetics (PK) studies in accordance with applicable guidelines. As a CRO, WAKENYAKU CO.,LTD. accepts contracts for pharmacology (PD), toxicology, and PK studies, performed in vitro and in vivo.

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

Contract Research Partners Available Through WAKENYAKU CO.,LTD.

FUJIFILM Wako Pure Chemical Corporation

Provides contract efficacy studies using PDX/CDX mouse models. Services include dosing anticancer agents in PDX mice and conducting efficacy evaluations. With an inventory of 2,700 PDX models, appropriate models can be selected for the compound based on genetic and pathological data as well as efficacy data for existing agents.

Funakoshi

Provides contract study services using domestic swine. Offerings include collection of intestinal contents, DIAAS (Digestible Indispensable Amino Acid Score) evaluations, cartilage transplantation studies in the knee joint, and gastrointestinal tract adhesion testing.

TRANS GENIC INC.

Provides nonclinical studies under licenses for genetically engineered mouse lines established and characterized at universities and research institutes. Available models include APPosk-Tg mice for Alzheimer’s disease, ProBDNF KI mice for psychiatric and neurologic diseases, SJLB mice for dementia, and IL33 Tg mice for atopic dermatitis. Comprehensive support is available from study design aligned with each disease hypothesis through high-quality data acquisition.

SetsuroTech

Provides end-to-end support for CRISPR/Cas9 genome-edited mouse creation, breeding, and phenotyping. Available assessments include blood and urine testing, toxicity studies, and safety pharmacology studies. Planning is available from the mouse-creation stage, including required animal numbers for each study. Additional support includes in vitro fertilization (IVF), natural mating, and cryopreservation of embryos and sperm.

Examples of Nonclinical Studies by WAKENYAKU CO.,LTD.

Pharmacodynamic/Pharmacology Studies (non-GLP)

Studies are conducted in an SPF environment using isocage systems and support non-GLP pharmacodynamic/pharmacology studies in mice and rats. Endpoints span antitumor efficacy, obesity, diabetes, and hypertension. Projects can be commissioned starting from a single mouse, at low cost, with rapid turnaround.

Reference: WAKENYAKU CO.,LTD. official website https://www.wakenyaku.co.jp/jtk/det.php?i=1251

Phenotypic Analysis of Genetically Engineered Animals

Phenotypic Analysis of Genetically Engineered Animals Studies are conducted in an SPF environment using isocage systems and support non-GLP pharmacodynamic/pharmacology studies in mice and rats. Assessments include general clinical observations, behavioral analysis, hematology, clinical chemistry, and gross and histopathology. Projects can be commissioned starting from a single mouse, at low cost, with rapid turnaround.

Reference: WAKENYAKU CO.,LTD. official websitehttps://www.wakenyaku.co.jp/jtk/det.php?i=1251

WAKENYAKU CO.,LTD. Company Information

Founded in 1972, WAKENYAKU CO.,LTD. has developed its business through its dealing and manufacturing divisions. The company provides researching and developing support in a variety of fields.

Address	17 Nishimizubo-cho, Ichijyoji, Sakyo-ku, Kyoto-shi, Kyoto, Japan
Tel	075-721-8111
Website	https://www.wakenyaku.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.

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.

Consult study design and disease model development
with SMC Laboratories, Inc.

Consult SMC Laboratories
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Safety Studies
Comprehensive Safety Evaluation for FIH Applications

Labcorp Holdings Inc.
(Labcorp Drug Development)

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.

Consult Labcorp Holdings Inc.
Discuss GLP/ICH-compliant study design for your FIH submission.

To labcorp.
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Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation

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.

Consult Phoenix Bio for PK/PD analysis with a clinical focus

Phoenix Bio.
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