Genetic Toxicology Services


Genotoxicity studies are one of the core modules in drug safety evaluation. We can provide sponsor with assays that comply with ICH-standard combinations, and our study protocol designs meet the requirements of guidelines issued by the FDA, EPA, ICH, OECD, and NMPA.

Trial project

Test System Configuration

• Bacterial reverse mutation (Ames) assay;

• In vivo chromosomal aberration assay in mammalian bone marrow cells;

• In vivo micronucleus assay in polychromatic erythrocytes of mammalian bone marrow;

• Chromosomal aberration assay in mammalian spermatogonia/spermatocytes;

• In vitro mammalian cell chromosome aberration assay;

• In vitro mammalian cell gene mutation assay.

Cell:

  Covers cell types including CHL, CHO, TK6, L5178Y, and 3T3.

Strain:

  • Salmonella typhimurium: TA97a, TA98, TA100, TA102, TA1535, TA1537;

  • Escherichia coli: E. coli WP2 uvrA, E. coli WP2 uvrA (PKM101).

  Note: All of the above cells and strains were obtained from ATCC or MOLTOX.

More fields


Medicine

As an institution in Shaanxi Province that has obtained NMPA drug GLP certification and completed its qualification re-examination and scope expansion in 2024, Guorui Yinuo has built a “global + domestic” dual-compliance service capability in the pharmaceutical sector.

Veterinary Drug

The one-stop service platform for veterinary drugs—GLP/GCP—is a specialized service provider that offers an integrated solution—from non-clinical evaluation to clinical trials and registration submission—aligned with both the Ministry of Agriculture and Rural Affairs’ GLP/GCP standards for veterinary drugs and the international OECD GLP standards, covering the entire R&D process for veterinary pharmaceuticals. At its core, this platform addresses the key pain points faced by companies, including long R&D cycles, high compliance barriers, and fragmented resources.

Pesticide

As the only organization in the Northwest region to have obtained OECD GLP certification in the pesticide field, Guorui Yinuo passed the international assessment with a zero-defect record. Relying on its compliance credentials, comprehensive technological capabilities across the entire value chain, and high-standard laboratory platform, Guorui Yinuo provides integrated solutions for global pesticide companies—from research and development all the way through registration.

Chemical substances

Relying on the OECD GLP zero-defect certification qualification, chemical test data can be globally recognized and simultaneously comply with both domestic and international chemical regulatory requirements as well as relevant requirements of the Ministry of Ecology and Environment, efficiently supporting needs such as chemical registration and export declarations.

Guo Rui Xin Chuang

Shaanxi Guorui Xinchuang Medical Technology Co., Ltd. is an independent, third-party clinical preclinical safety evaluation research institution for medical devices. It was registered and established in June 2020 in the Airport New City and is currently the most comprehensive medical device safety evaluation institution in Northwest China. The company primarily provides product safety evaluation services to R&D enterprises specializing in Class II and Class III medical devices.

Hua Xin Yi Nuo

A full-process technology empowerment platform from target discovery to IND submission

Early Toxicity Prediction and Screening

Early toxicity screening is an essential and indispensable step in the new drug development process. Early termination of compounds that show no development potential can save sponsor substantial amounts of manpower, resources, and time. We offer sponsor comprehensive early toxicity screening services, including early genotoxicity assessment, early general toxicity assessment, and early reproductive and developmental toxicity assessment.

Pharmacodynamic studies

We are equipped with specialized instruments and devices, including flow cytometers, microplate readers, fluorescence microscopes, and PCR machines. These resources enable us to establish animal models for diseases affecting the tumor, cardiovascular, respiratory, metabolic, and urinary systems, and to conduct comprehensive and systematic preclinical studies on drug efficacy and mechanisms at multiple levels.

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