KPSCS comprises in-vivo efficacy and pre-clinical safety studies for cell-based therapies, proteins and chemical entities. The pre-clinical facilities which are CPCSEA approved, are located at the R V Northland Institute Centre of KPS Clinical Services, Greater Noida. The salient features are:
State-of-the-art, barrier maintained facility with rich environmental monitoring system
Studies in compliance with CPCSEA guideline and principles of Good Laboratory Practice (GLP)
Conduct of chronic studies in Specific Pathogen Free animals
Fully automated clinical and histopathology laboratory with highly skilled pathologists and technicians
Highly qualified professionals experienced in GLP certified labs to conduct toxicity studies
Independent QA team to conduct study, process and facility based inspections
Regulatory Toxicology |
General Toxicology |
Acute Toxicology, Sub-Chronic Toxicity Studies and Chronic Toxicity Studies by Oral and Parenteral Routes |
Local Tissue Tolerance Studies |
Sensitization Studies
Skin Irritation Studies |
Mutagenicity Studies |
In vitro: Ames and Mouse Lymphoma Tk assay
In vivo: Micronucleus and Chromosomal Aberration test |
Bio efficacy studies of biotechnologically derived products |
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