EN
We have a bioanalysis laboratory in Shanghai Zhangjiang High-Tech Park (subsidiary of UnionClin: Shanghai Hongren Biopharmaceutical Co., Ltd.), primarily providing bioanalytical and pharmacokinetic research services for various chemical drugs and biological products. Based on model-guided innovative drug development, through scientific design, dose group optimization, and support for dynamic decision-making, we help significantly shorten clinical trial timeline and costs, safeguarding new drug research and development.
Clinical PK studies for chemical innovative drugs
Bioequivalence studies of chemical generic drugs
Pharmacokinetics/Toxicokinetics studies (PK/TK)
Immunogenicity studies (ADA/Nab)
Biomarker studies (Biomarker)
Pharmacogenetics studies (PG)
Cell therapy studies (CT)
Immunohistochemistry studies (IHC)
500+ biological sample analyses, 300+ development drug analytical tests, 100+ passed CFDI on-site inspections, 20+ China-US simultaneous submissions projects
Chemical Drugs, Peptides, Monoclonal Antibodies, Bispecific Antibodies, Oncolytic Viruses, Immune Cells, Stem Cells, Vaccines, Nucleic Acid Drugs, etc.
Core team with over 8 years of experience
Over 200 analysis and testing instruments
Certified by the National Health Commission's inter-laboratory quality evaluation, National Institute for Food and Drug Control capability certification, CNAS17025 accreditation, Biosafety Level 2 laboratory filing, etc. Over 100 projects passed CFDI on-site inspections
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