Drug Registration

Administrative documents, CMC materials, preclinical study materials, clinical study materials, eCTD editing and organizing

CMC: specification, manufacturing process, process validation, method validation, stability study, etc.;

Preclinical study: pharmacological, pharmacodynamic and toxicological study reports, etc.;

Clinical study: clinical study protocol, investigator's brochure, clinical study report, CRF, ICF, ethical approval, safety study report, clinical literature, etc.