One stop solution for safety evaluation – IND, NDA enabling and other safety studies.
Our expertise for global IND-enabling safety evaluation spans across mammalian toxicology, genetic toxicology, DMPK, and bio-analysis during the preclinical stage of drug development including method development, validation, impurity profiling, impurity isolation, characterization, certification and evaluation for qualification.
In addition, Bioneeds’ NDA/ANDA enabling safety evaluations encompasses a comprehensive portfolio of ADMET assays.
Our scientific team led by domain experts has helped clients in successful & timely submissions over the years.
Compound Synthesis: Importantly, Bioneeds can also generate the test material required for preclinical evaluation in its state-of-the-art Chemistry facility.
Exploratory Toxicology Studies: Dose limiting toxicology studies Dose escalation toxicology studies