Implementing Integrated Services
Integrated drug R&D services at Pharmaron comprise drug discovery, preclinical development and clinical development.
The integrated drug discovery service employs medicinal chemistry and computer-aided drug design, DMPK, in vitro biology, in vivo pharmacology, discovery process chemistry and exploratory toxicology capabilities. In this way, Pharmaron discovers and advances small molecules through different project stages, such as hit identification, lead identification, lead optimization and PCC selection.
Integrated preclinical development services enable IND submission to regulatory authorities, including FDA, CFDA and EMA. Our technology platforms include regulatory DMPK, in vivo pharmacology, safety assessment and CMC.
Clinical development services include clinical research from FIH to POC, which encompass SAD/MAD, TQT, PK, safety, tolerability, food effect, clinical pathology, clinical bioanalysis and clinical metabolism studies, etc. As part of clinical development, we also offer CMC services consisting of process chemistry and cGMP API manufacturing as well as formulation development and cGMP drug product manufacturing.