C-TASC staff follows the ICH M3 (R2) guidance for the conduct of non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals. To achieve this, C-TASC staff has a teaming agreement with a pre-clinical testing agency in the Boston area, which can quickly and efficiently complete the following studies and integrate them into C-TASC overall clinical development plan for your treatment or device: safety pharmacology, toxicokinetic and pharmacokinetic studies, acute toxicities studies, repeated dose toxicities studies, estimation of first dose in humans, exploratory clinical studies which include microdose studies, single dose studies and multiple dose studies, local tolerance studies, genotoxicity studies, carcinogenicity studies, reproduction toxicity studies covering men and women of child bearing potential, immunotoxicity, phototoxicity, non-clinical abuse liability, and combination drug testing. C-TASC’s clinical development plan will ensure that each of these studies are conducted at the appropriate time so that the necessary pre-clinical information is present at pre-IND meetings and end of phase II meeting with the FDA, which constitute the two most important meetings with that regulatory agency.