Preclinical
services (OECD GLP certified Toxicology Centre)
The Preclinical Services offered by RCRS comprises
in-vivo efficacy and pre-clinical safety studies
for cell-based therapies, proteins and chemical
entities. The pre-clinical facilities which
are OECD certified, are located at the Dhirubhai
Ambani Life Sciences Centre of Reliance Life
Sciences, Navi Mumbai. The salient features
are:
State-of-the-art, barrier
maintained facility with robust environmental
monitoring system
Studies in compliance with OECD 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
The experience and capabilities include:
Regulatory
Toxicology |
| General Toxicology |
Acute Toxicology, Sub-Chronic
Toxicity Studies and Chronic Toxicity
Studies by Ooral 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 |
Reliance Preclinical Services is registered
with the Committee for the Purpose of Control
and Supervision of Experiments on Animals (CPCSEA)
and conforms to its guidelines
|
