Bridging drug discovery, and clinical studies, the preclinical development stage is an iterative process that involves several critical steps, including chemical scale-up, formulation development, bioanalysis, DMPK, toxicology testing, and clinical trial supply preparation. Each of these steps is essential to ensure that a potential new drug candidate is safe and effective before it is tested in humans. Through careful planning and rigorous testing, our researchers can identify promising drug candidates that have the potential to improve the lives of patients around the world.

To evaluate any serious harmful potentials of a drug, toxicology assays are conducted, while DMPK assays are carried out to support ADME properties assessment. These studies are performed by our experts in bioanalysis, who check accurate dosage levels and measure drug and metabolite concentration levels in biological matrices.

In parallel, the chemical properties of the drug candidate, such as solubility or stability, also influence its performance. An efficient chemical development route design and formulation development are also key to ensuring the efficacy of a drug candidate.

To maintain the quality of your drug from lab to shelf, our analytical development and QC team has extensive experience in designing reliable and robust analytical test methods. While moving from bench to bedside, our clinical trial supply experts can support the manufacturing of your medicinal products for use in Phases I–IV clinical studies, as well as compassionate use/expanded access programs.

Our preclinical solutions cover: