Protheragen is a specialized radiopharmaceutical CRDMO and CRO platform dedicated to accelerating the development of targeted radiotherapies and molecular imaging agents. We integrate end-to-end capabilities spanning drug discovery, preclinical evaluation, IIT clinical trials, and cGMP manufacturing — enabling our partners to transform novel targeting concepts into clinical-ready radiopharmaceuticals with speed, precision, and regulatory confidence.
We identify and validate tumor-specific targets, then optimize lead compounds for radiopharmaceutical development. From hit screening to precursor design, our integrated discovery platform accelerates the journey from biological concept to clinic-ready radioligand.
Our in vitro and in vivo capabilities evaluate targeting, pharmacokinetics, toxicity, and efficacy across multiple species. With AAALAC-accredited facilities and GLP-like standards, we generate the data package required for IND submission and clinical translation.
We design, execute, and manage investigator-initiated trials from protocol to final report. Integrated clinical supply, imaging analysis, and regulatory navigation enable first-in-human data within six to nine months.
PET/CT, SPECT/CT, MRI, and optical imaging visualize radiopharmaceutical targeting in real time. Advanced quantitative analysis and dynamic kinetic modeling deliver the biomarker evidence to de-risk and accelerate clinical development.
We establish and validate analytical methods, impurity profiles, and stability protocols that meet global regulatory standards.
We integrate CMC, preclinical, and regulatory documentation to prepare and submit comprehensive IND packages for NMPA, FDA, and EMA.
