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CELLPURICS

GLOBAL CRO SERVICE

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