Safety Assessment
Model: CRO
Category: *CRO
Exhibitor: BIOMED LINKAGE TECH CO., LTD.
Booth No: M1105
Characteristic
We provide comprehensive toxicology study support.
For IND-enabling programs, our services include general toxicology studies across multiple species, including rodents, rabbits, dogs, non-human primates (NHPs), and minipigs. We also support genetic toxicology studies, including Ames, chromosomal aberration, and micronucleus assays, as well as a series of safety pharmacology studies.
For NDA-enabling programs, we provide chronic and subchronic toxicology, reproductive toxicology, and carcinogenicity studies to support regulatory approval.
Through our partnered GLP-compliant CROs, studies are conducted in accordance with major international regulatory guidelines and requirements, including those of OECD, FDA, NMPA, and PMDA, supporting submissions to FDA, EMA, NMPA, PMDA, MFDS, and other regulatory authorities.
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