We provide services including safety evaluation of pharmaceutical injectables, genotoxicity safety evaluation of drugs, pharmacokinetic studies, pharmacodynamic studies, respiratory toxicology studies, reproductive toxicology studies, bioequivalence assessment of generic drugs, safety and efficacy evaluation of medical devices, non-clinical and clinical safety evaluation of veterinary drugs, drug testing, packaging material testing, and more for pharmaceutical and medical device R&D institutions, research institutes, and pharmaceutical companies.
Technical services
Genotoxicity studies can predict the genotoxic effects of drugs and chemicals, including mutagenicity, clastogenicity, and DNA damage. We offer all assays included in the ICH S2(R1) standard battery and comply with international GLP regulatory guidelines. Our assay protocols are designed to meet the requirements of guidance documents issued by the U.S. FDA, U.S. EPA, ICH, OECD, and CFDA. Years of accumulated extensive historical control databases, a stable technical team, and highly qualified senior researchers ensure that we can provide our clients with high-quality services promptly and effectively. We are committed to developing cutting-edge genotoxicity methodologies and applying automated systems such as flow cytometry to genotoxicity research. We have participated multiple times in collaborative validation studies of new genotoxicity technologies and methods both domestically and internationally. In addition to the ICH standard assay battery, we can also provide clients with studies on genotoxicity mechanisms and additional assay methods, as well as genotoxicity assessments of impurities that meet the requirements of ICH M7.
Developmental and Reproductive Toxicology
Developmental and Reproductive Toxicology (DART) studies are an essential component of safety assessments for pharmaceuticals and chemicals (ICH M3, S5, S6; OECD 421, 422, 443, 414, 415, 416). Our DART department boasts extensive experience and can provide clients with a comprehensive suite of reproductive and developmental toxicity tests that comply with the guidelines set forth by the U.S. FDA, U.S. EPA, ICH, OECD, and CFDA. All tests are conducted in strict adherence to international GLP regulatory standards. Our years of accumulated historical control databases, a stable technical team, and highly qualified senior researchers ensure that we can deliver high-quality services to our clients promptly and efficiently.
The safety tests for pharmaceutical formulations primarily include irritation, sensitization, and hemolytic tests. These tests evaluate the toxicity—such as local irritation and local allergic reactions—that may occur at the site of administration when a drug formulation is administered via non-oral routes, including through the skin, mucous membranes, body cavities, and blood vessels, as well as any systemic toxicity—such as systemic allergic reactions and hemolysis—that may arise from systemic exposure. These tests are an integral part of preclinical safety evaluation.
We have an experienced team of toxicology specialists and a team of highly qualified experts—both domestic and international—who can provide clients with scientifically sound study designs and dose selections to ensure the smooth conduct of toxicology studies. Our general toxicology studies comply with international GLP regulatory standards, and our study designs meet the requirements of relevant guidelines issued by the NMPA (CFDA), U.S. FDA, OECD, and ICH, enabling us to satisfy the requirements for clinical trial applications or market approvals in various countries and regions.
Early Toxicity Prediction and Screening
Drug safety issues are a major factor contributing to drug development failures and one of the primary reasons for withdrawing marketed drugs from the market. Traditionally, toxicity testing and safety evaluations of drugs have been conducted during the non-clinical phase through animal studies. Once serious toxic reactions are identified, leading to development failures, this can result in substantial economic losses. Conducting ion channel and cell-level toxicity tests early in the drug development process can significantly reduce the likelihood of later-stage development failures, thereby increasing the success rate of drug development and lowering R&D costs.
In vivo pharmacokinetic studies
Animal species: Mouse/Rat/Rabbit/Dog/Crab-eating Macaque/Indian Rhesus Monkey/Miniature Pig/Model Animals, etc. Route of administration: intravenous/oral/subcutaneous/intraperitoneal/muscular/local administration, etc. Biomatrix Collection: Blood/plasma/serum/urine and feces/bile/various tissues Microsampling: one mouse, one PK Detection methods: LC-MS/MS, LC-QTOF, RT-PCR, ELISA, radioisotope labeling, etc. Data Analysis: Phoenix WinNonlin and Gastrol plus are used for PK/PD and PBPK calculations and simulations. Specialized Service: Non-clinical Pharmacokinetic Studies of Radioisotope-Labeled Compounds
Inhibition assays: 1) Reversible inhibition 2) Time-dependent inhibition Metabolic Phenotype Assays: 1) CYP—chemical inhibition and recombinant enzyme methods; 2) UGT—recombinant enzyme method. Enzyme induction: CYP450 enzyme subtypes (1A2, 2B6, and 3A4) Transporter Assay: ABC transporter substrate assays (P-gp and BCRP); vesicle systems or Caco-2 cells; ABC Transporter Substrate Inhibition Assay (P-gp and BCRP): Vesicle System; SLC Transporter Substrate Assays (OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, MATE2K) SLC Transporter Inhibition Assays (OATP1B1, OATP1B3, OAT1, OAT3, OCT2, MATE1, MATE2K)
Metabolic cage collection of urine and feces for LC-MS/MS analysis Rat bile duct cannulation and bile collection for LC-MS/MS analysis. After radiolabeling with 3H/14C isotopes, the radioactivity in feces, urine, and bile is measured (online radioactivity monitoring—HPLC-mass spectrometry). 125I-labeled drug, determination of total radioactivity in feces, urine, and bile
Contact phone number
Ms. Li:+86 15760970681
Mr. Su:+86 19991001701
Landline:+86-29-33656828
Company Address
4th Floor, Unit C. Building 9. Small and Medium-sized
Enterprise Park, Airport Industrial Zone Airport New Ciy,Xixian New Area, Shaanxi Province
©2026 Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd.
WhatsApp：8613940397353
Email：hr-xian@grglp.com
Landline：862933656828
Mr. Su：8619991001701
Ms. Li：8615760970681