· GLP Certification: Multi-jurisdictional recognition by NMPA, FDA, OECD, MFDS and PMDA
· Animal Welfare Certification: AAALAC International accredited
· Compliance Standards: ICH, FDA, EMA, NMPA, ISO 10993, GB/T 16886
| Test Article Type | Available Test Items | Core Advantages |
| Innovative small-molecule drugs | Full-cycle general toxicology, reproductive & genetic toxicology, carcinogenicity | Industry-leading experience in first-in-class drug evaluation |
| Biologics / Vaccines / Cell products | Immunogenicity, special safety evaluation, toxicokinetics | High-sensitivity detection with fully GLP-compliant data |
| Medical devices (implantable / interventional / drug-device combination) | Extract toxicity, local toxicity, biocompatibility | ISO 10993-aligned, dedicated medical device evaluation system |
| TCM / Natural products / Antibiotics | Subchronic / chronic toxicity, target organ evaluation | 30-year historical database and accurate pathological diagnosis |
By single and repeated dose exposure studies, we systematically evaluate acute, subacute, subchronic and chronic toxic responses of test articles, define toxic dose ranges, target organ damage and lesion reversibility. The data support clinical dose design and safety margin determination, serving as mandatory safety evaluation packages for new drugs and high-risk medical devices.
Core Services
· Dose-range finding toxicity study
· Acute toxicity study
· Subacute toxicity study
· Subchronic toxicity study
· Chronic toxicity study
Rodents: Mice, hamsters, rats, guinea pigs.
Non-rodents: Rabbits, dogs, minipigs, non-human primates, etc.
Traditional Chinese medicines, TCM decoction pieces, proprietary Chinese medicines, integrated Chinese and Western medicines.
Chemical API and formulations, antibiotics.
Biochemical drugs, radioactive drugs, sera, vaccines, blood products, cell products, diagnostic reagents.
In vivo Administration：Oral administration.
Injection administration: intramuscular, intraperitoneal, subcutaneous, intravenous (bolus, infusion, continuous infusion).
Topical Administration：Dermal application / patch / intradermal injection.
Ocular administration (conjunctival sac, vitreous cavity, retrobulbar, retinal injection); inhalation / intratracheal administration; nasal administration; vaginal administration; stereotactic intracerebral injection; intra-articular injection; intraspinal injection; intrathecal injection & continuous infusion.
Core Service Advantages
Global Regulatory Compliance: Fully accredited by NMPA, FDA, OECD, PMDA and MFDS with AAALAC animal welfare certification. Study data are globally recognized and directly support worldwide IND/NDA and medical device registration.
Full-coverage Test Articles: Capable of evaluating chemicals, TCM, biologics, vaccines, cell products, drug-device combinations and implantable devices, providing one-stop full-package toxicology solutions.
Customized Multi-model Solutions: Rich rodent and non-rodent animal models and comprehensive administration routes enable tailored study designs based on compound characteristics and clinical usage.
Professional Technical & Pathological Support: Decades of toxicology experience and complete historical background data ensure accurate target organ toxicity identification and reversibility judgment, effectively reducing regulatory risks.
Dual Standard System Adaptation: Compliant with drug toxicity guidelines as well as ISO 10993 / GB/T 16886 biocompatibility standards, covering innovative drugs, generic drugs and medical devices.
Efficient Project Delivery: Standardized SOPs and full-process digital management ensure high-quality, time-efficient study execution, accelerating clinical progression and product launch.
Full-cycle General Toxicology for Innovative Anti-tumor Small Molecule
We provided full-range dose-finding, acute and subchronic toxicity services for a first-in-class anti-tumor drug. A customized non-human primate study design was adopted based on compound properties. Full GLP-compliant data supported successful one-time FDA IND approval with no regulatory questions, greatly shortening the R&D cycle.
Toxicology Evaluation for Orthopedic Implantable Medical Device
Conducted extract acute toxicity, local toxicity and subchronic toxicity tests for a permanent orthopedic implant in strict accordance with ISO 10993 using canine models. The validated data obtained NMPA recognition and accelerated device registration approval.
Subchronic Toxicity Study for Innovative TCM Formula
Performed a 90-day subchronic toxicity study for an innovative TCM formula. Optimized administration routes and detection indicators were applied to accurately screen potential target organ toxicity. Complete GLP reports supported successful clinical trial approval.
