Iwase Cosfa Co.,Ltd.

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.

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.

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.

Company Information

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