Project Description

India FDA GLP Preclinical Laboratory needed for Animal toxicity studies, pharmcokinetics water soluble chemical entity (to be supplemented orally), for which we have to perform the clinical trials. For this, pre-clinical toxicity studies need to be carried out by a GLP certified laboratory.
Contractual services are required to carry out these studies viz; animal toxicology, pharmacology, pharmacokinetics and/or related studies which are mandatory before getting approval for clinical trials.
Also whether the data generated would be compliant to support the IND application as well?