Certifications, Accreditations, Licenses:
- GLP since 1992
- Largest AAALAC certified animal vivarium in India, one of Asia's largest regulatory toxicology facilities
- Submitted 35 complete IND packages (late lead optimization through IND) (11 with USFDA, 6 with TPP Health Canada, 6 with EMA, 2 with MHRA, 1 each with AEMPS Spain, HSA Singapore, Medsafe New Zealand, TGA Australia and NGCMA India), all of them getting FIH approvals without clinical hold
- 7000 standalone Toxicology studies submitted to regulatory agencies worldwide
- 56 Carcinogenicity studies including in RasH2 & p53 Transgenic mouse models
- Robust historical control data from sub-chronic & chronic studies in rodents (including SD rats) & non-rodents available on Body weight & feed intake, Hematology and Clinical Chemistry, Histopathology, Tumor incidence, Teratology, Mutagenicity, etc.
- 68 study directors including 6 DABTs, and over 110 scientists of whom 65% have either a Ph.D., M.S. (biology) or D.V.M degree including 25 trained histologists
- Histopathology: Team of 5 Veterinary pathologists headed by a globally preeminent pathologist with >35 years of experience who has authored over 300 safety evaluation study reports including 28 carcinogenicity studies
**Important Note: This information has been provided by the Company and has not been confirmed by Contract Laboratory Inc. It is recommended that you confirm all information prior to using this company.