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CELLPURICS

GLOBAL CRO SERVICE

Non-clinical safety assessment

셀퓨릭스
안전하고 신속한
신약 개발의
길을 안내합니다.

셀퓨릭스의 해외 GLP 시험 서비스는 전세계 주요 시작인 미국, 유럽, 중국 그리고 국내에서 의약품 승인에 관련된 풍부한 경험을 보유한 중국 최고 수준의 GLP CRO업체들을 통해 제공됩니다.
현지의 독성 시험 전문가들은 실시간으로 이 프로세스를 관리하여 우수한 품질과 효율적인 소통, 합리적인 가격, 정확한 일정을 보장합니다.

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