Non-clinical safety assessment

We offer
a safe and
fast way of
drug discovery.

Our overseas GLP testing services are delivered by China's top-tier GLP CROs with a wealth of experience in drug approvals in the world's major markets including the US, Europe, China, and Korea.
The local non-clinical toxicology experts manage this process in real-time, ensuring superb quality, efficient
communication, reasonable prices, and accurate schedules.

SAFETY ASSESSMENT SERVICES

Discovery Studies

Exploratory general, genetic and in vitro toxicology

Ocular PD

NDA enabling/Post market Studies

Chronic/ subchronic toxicology
→ 13 weeks & 26/39 weeks

Carcinogenicity study
(2 year rat/mouse, and 26 weeks rasH2 transgenic mice)

Reproductive toxicology (Seg I, Seg II, SegIII)

AE investigative type studies

IND-enabling Studies

General toxicology (rodent, rabbit, dog, NHP, minipig)
: 14 days & 28 days

Genetic and in vitro toxicology
: Genetic Toxicology
(Ames, chromosomal aberration, micronucleus, MLA, Comet)
: In Vitro Electrophysiology (hERG)
: In Vitro Phototoxicity (3T3 NRU Phototox)Safety pharmacology

Safety pharmacology
: Screening
: Core battery

Developmental and reproductive toxicology
: Seg1 Fertility (rat)
: Seg2 Emboyo-fetal developmental (rat & rabbit)
: Seg3 Prenatal and postnatal developmental (rat)
: Seg4 Multi-generation

Local tolerance

LABORATORY SERVICES

Analytical chemistry

Method transfer, development, validation and sample analysis

Bioanalysis : TK modeling

Method transfer, development, validation and sample analysis

Immunology

Immunohistochemistry

Flow cytometry

Immunochemistry

Tissue cross reactivity (rat, dog, monkey, human)

Immunogenicity or ADA assay

Bioanalysis

Biomarkers

RT-qPCR assay

SEND

SEND data sets available within 10 working days of report date

NMPA GLP Certification
AAALAC Accreditation
US FDA GLP Inspection
OECD GLP Certification
MFDS GLP Inspection
US CAP Inspection
CNAS Certification
PMDA GLP Inspection
US NIH OLAW Accreditation

GLOBAL CRO SERVICE