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Iwase Cosfa Co.,Ltd.

Table of Contents

Iwase Cosfa Co.,Ltd. serves as the exclusive Japanese agent for contracted clinical safety studies. This page introduces the key features of Iwase Cosfa Co.,Ltd.’s non-clinical testing services, examples of pathological models, and case studies.
We hope you can use this information as a reference when selecting an CRO for you non-clinical needs.

Non-Clinical Studies Conducted by Iwase Cosfa Co.,Ltd.

Comprehensive Safety Testing Across Multiple Fields

Iwase Cosfa Co.,Ltd. conducts safety evaluations across a broad range of industries, including cosmetics, quasi-drugs, food, chemicals, agriculture chemicals, and pharmaceuticals. They offer many testing such as acute toxicity (single-dose/oral and dermal), genotoxicity (Ames/chromosomal aberration), skin irritation (patch test/cumulative irritation), and environmental toxicity (aquatic life impact assessment). Through their partnership with BIOTOXTECH in South Korea, the company has established a GLP-compliant testing platform for international standards (FDA/ICH), providing end-to-end safety evaluation from raw material screening to pre-market assessment. Iwase Cosfa Co.,Ltd. also focuses on alternative methods to animal testing, particularly in line with the EU Cosmetics Directive, offering strong regulatory adaptability.

Proprietary Efficacy Evaluation Technologies

Specializing in dermatological assessments, the company conducts tests such as collagen and hyaluronic acid production, anti-wrinkle efficacy (56-day human clinical trial), whitening (melanin suppression), and hair tensile strength. Its proprietary “Wrinkle Reset” formulation has demonstrated anti-wrinkle effects in both non-clinical studies (fibroblast activation) and human trials (improvement of facial sagging in 40 subjects). This enables packaged service proposals covering everything from formulation design to efficacy data acquisition. In non-comedogenic testing, acne formation risk is statistically evaluated using the occlusive patch method with Finn Chambers.

International Collaboration and Quality Assurance

As the exclusive Japanese representative for BIOTOXTECH, Iwase Cosfa Co.,Ltd. offers integrated services from study designing to data management at GLP-certified facilities. Through their joint research with Kyoto University’s Virus Research Institute, the company has developed a virus inactivation verification method applied to biological safety assurance of raw materials. In addition to their ISO9001 and ISO13485-compliant quality management systems, they also have expertise in preparing application materials for PMDA and EU regulatory authorities. They have set up more strict study protocols for subject selection criteria (differences in sensory irritation scores between positive/negative control substances) and evaluation timing (immediate, 2.5 minutes, and 5 minutes post-application), ensuring high reproducibility and reliability.

3 Specialized Pre-clinical CROs for Advanced Drug Discovery

Partnered Contract Research Organization

BIOTOXTECH Co., Ltd.

A South Korea-based company who provides safety evaluation services for pharmaceuticals, foods, cosmetics, chemicals, and agrochemicals. BIOTOXTECH supports pharmaceutical and agrochemical regulatory submissions as well as exploratory and screening studies for internal research.

Iwase Cosfa Co.,Ltd.’s Non-Clinical Case Studies

Toxicology Studies

Iwase Cosfa Co.,Ltd. evaluates the efficacy of raw materials and products towards humans and effects on environment. Applicable to quasi-drugs, food-related products, chemicals, and consumer goods, the company offers acute toxicity, genotoxicity, irritation, sensitization, patch, repeated-dose toxicity, and environmental toxicity tests.

Reference:https://www.cosfa.co.jp/business/biox/exam.html

Efficacy Studies

They offer efficacy studies for ingredients in raw materials and finished products. Areas of focus include skin aging, whitening, allergy, and hair care. Test types include collagen and hyaluronic acid production, cell activation, skin moisturization, anti-wrinkle, whitening, inflammatory response suppression, alkaline phosphatase (ALP) activity, hair papilla cell activation, hair growth, hair moisture content, and hair tensile strength tests.

Reference:https://www.cosfa.co.jp/business/biox/exam.html

Company Information

Partnered with BIOTOXTECH in Korea, Iwase Cosfa Co.,Ltd. serves as the exclusive Japanese agent for contracted clinical safety studies.

Address	1-7-11 Doshomachi, Chuo-ku, Osaka-shi, Osaka
Tel	06-6231-3456
Website	https://www.cosfa.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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