The safety assessment services

The safety assessment services offered by BioMed Linkage, categorized into IND-enabling Studies and NDA-enabling/Post-market Studies.

IND-enabling Studies:

1. General Toxicology: Studies conducted in rodents, rabbits, dogs, NHPs, and minipigs for 14-day and 28-day durations.
2. Genetic Toxicology: Includes tests such as Ames, Chromosomal Aberration, Micronucleus, MLA, and Comet assays.
3. Safety Pharmacology: Covers screening and core battery studies.
4. In-vitro Toxicology: Includes hERG (electrophysiology) and phototoxicity studies.
5. Reproductive Toxicology: Segments I, II, and III.
6. Local Tolerance: Evaluation of tolerability at application sites.

NDA-enabling/Post-market Studies:

1. Chronic/Subchronic Toxicology: Studies spanning 13 weeks and 26/39 weeks.
2. Reproductive Toxicology: Segments I, II, and III.
3. Carcinogenicity Studies: Includes 2-year studies in rats/mice and 26-week studies in rasH2 transgenic mice.

The services adhere to global regulatory standards set by agencies like the FDA, NMPA, EMA, PMDA, and MFDS, ensuring compliance with OECD guidelines. The company positions itself as a leading GLP-compliant CRO in China.