Technical services
Non-clinical safety evaluation
Light is beneficial to health, and many medications themselves do not harm the human body. However, under the influence of light, certain drugs can induce phototoxicity. In such cases, it becomes necessary to conduct a phototoxicity assessment. We have established both in vivo and in vitro phototoxicity evaluation methods in accordance with the requirements of ICH S10 and NMPA, and we have over ten years of experience in dermatological phototoxicity assessments.
We conduct safety and efficacy evaluations of ophthalmic drugs, as well as studies on the effects of systemic drug administration on the eyes. We are proficient in various intraocular drug delivery methods across different animal species and have established experimental animal models for conditions such as corneal neovascularization, corneal epithelial damage, and cataracts. Equipped with advanced ophthalmic diagnostic instruments—including slit lamps, tonometers, fundus cameras, OCT systems, electroretinographs, and surgical microscopes—we are able to perform comprehensive in vivo ophthalmic examinations, thereby providing crucial support for preclinical research on ophthalmic drugs.
We offer clinical pathology testing services for non-clinical drug evaluation and clinical trials, and can develop new assay methods and conduct methodological validation according to customer requirements.
The Department of Pathology boasts an experienced and highly skilled pathology team, equipped with advanced imported instruments and a digital pathology diagnostic system. We offer a comprehensive array of pathology staining techniques and are capable of providing remote pathology diagnostic services. All experimental designs and procedures comply with international GLP standards, ensuring the accuracy and reliability of our test results. We conduct toxicological pathology evaluations on a wide range of animal models, including mice, rats, rabbits, dogs, and non-human primates. Our team includes a Japan College of Veterinary Pathology-certified veterinary pathologist and a Japan Society of Toxicologic Pathology-certified toxicologic pathologist, guaranteeing high-quality and precise pathology diagnoses and toxicologic pathology evaluation reports. We are committed to delivering top-notch toxicologic pathology evaluation services to our clients.
Small-molecule bioanalysis is a branch of analytical chemistry that focuses on the quantitative determination of small-molecule compounds as well as certain macromolecules (such as proteins, DNA, metabolites, and large-molecule drugs). In recent years, biotechnology-based drugs have become a major research and development focus, and bioanalysis has gradually attracted increasing attention from companies due to its critical role in the early stages of biotech drug development. We have a highly specialized research team, an analytical laboratory equipped with state-of-the-art instruments and devices, and a fully integrated information management system. Our experimental studies comply with GLP standards, and we develop, transfer, and optimize LC-MS/MS methods for the quantification of drug concentrations in biological matrices. Our services encompass the development, validation, and transfer of bioanalytical methods, as well as bioanalytical method verification; toxicokinetic and pharmacokinetic sample analysis—including plasma, serum, tumor tissues, heart, liver, spleen, lung, kidney, duodenum, body fat, skeletal muscle, testes, and ovaries—and the calculation of toxicokinetic and pharmacokinetic parameters. We provide non-clinical research services for small-molecule drugs, biologics, and other similar substances to our clients.
The purpose of safety pharmacology studies is to identify unexpected pharmacological effects that may be relevant to clinical safety, evaluate adverse pharmacological or pathophysiological responses observed in toxicology studies or clinical trials, and explore the underlying mechanisms responsible for these adverse reactions. We have an experienced team of safety pharmacology specialists and advanced, fully equipped imported experimental facilities, enabling us to provide clients with a comprehensive suite of safety pharmacology testing services that comply with CFDA, ICH S7A and S7B guidelines, as well as international GLP standards.
Carcinogenicity testing is conducted to evaluate the potential carcinogenic effects of a drug in animals, thereby assessing and predicting its possible hazards to humans. Any concerns arising from experimental studies, animal toxicity tests, or data from human applications may indicate the need for carcinogenicity testing. Drugs expected to be used by patients over a long period should undergo carcinogenicity testing in rodent species. We were among the first in China to conduct carcinogenicity studies under GLP-compliant conditions and have established a comprehensive carcinogenicity evaluation system. The study designs fully comply with the guidelines of the FDA, ICH, and CFDA and adhere to international GLP standards.
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.