General Toxicological Safety Assessment


Our company’s core team boasts extensive experience in toxicology research and has conducted hundreds of drug projects as well as thousands of general toxicology studies for pesticides on behalf of our sponsor. Our product portfolio encompasses chemical pharmaceuticals, biotechnology products, traditional Chinese herbal medicines, and chemicals of various kinds. We are able to provide sponsor with sound study designs and appropriate dose selections, ensuring the smooth execution of toxicology studies. Our general toxicology studies comply with international GLP regulatory standards and can be tailored to meet the regulatory requirements of different countries, thereby satisfying sponsor’ needs for clinical trial applications or market authorization.

Type of experiment

1. Dose Range Determination StudyClearly define the safe dosage range of the drug to lay the foundation for subsequent trials.
2. Single-Dose Toxicity StudyAssess the acute toxicity response following a single dose of the drug;
3. Repeated-dose toxicity studies accompanied by toxicokineticsSupports 1-, 3-, 6-, and 12-month cycles, enabling the analysis of toxicity profiles and toxicokinetic patterns associated with long-term administration.
4. Local Toxicity TestEvaluate the irritation and toxic reactions of the drug at the local administration site.
5. Immunogenicity TestVerify whether the drug triggers immune-related adverse reactions;
6. Safety pharmacology studiesAssess the effects of the drug on the body's major physiological systems.

Experimental route of administration

Covering multiple administration routes including oral (gavage, capsules), topical (skin and mucous membranes), intravenous (bolus injection/continuous infusion), subcutaneous, intradermal, intramuscular injection, ocular, and respiratory;

Types of test substances

Supports the evaluation of a wide range of study materials, including chemical drugs, biological products, traditional Chinese medicines, and natural medicines.

Test animal species

We offer a variety of experimental animal options, including rodents and non-rodent species.

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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