Shanghai-Hong Kong Zhongke

Biopharmaceutical preclinical research and development service company

Copyright © AnLing Biomed (Suzhou) Co., Ltd. All Rights Reserved Source:Boooming ICP:粤ICP备2022021434号-2 CNZZ

Drug Safety Evaluation Division

Team Background

The drug safety evaluation team of ZSHK Laboratories Limited, composed of core members from Center for Drug Safety Evaluation and Research of Shanghai Institute of Materia Medica who participated in the whole process of building a drug safety evaluation platform that became the first that complies with the international GLP standards, and was awarded the most international GLP certifications (US FDA, UK MHRA and Sweden and Belgium regulatory authorities) in China. A number of new drug safety evaluation projects were completed with high quality: More than 100 early toxicity screening methods and models were established. Safety evaluation has been completed for 320 domestic or foreign new drugs involving more than 1,500 compounds, among which 50 were submitted for or allowed to proceed to clinical trials by US FDA, UK, OECD, etc., and 100 were domestic innovative drugs subsequently granted new drug approvals or clinical approvals.

Featured Services

◆ A full set of new drug safety evaluation experiments complying with FDA/OECD/NMPA GLP standards, including small molecules and macromolecules, with Chinese and English reports available; including general toxicity studies in large and small animals, and studies of safety pharmacology, carcinogenicity, reproductive toxicity, genetic toxicity, formulation safety, immunogenicity and immunotoxicity, toxicokinetics, etc.
◆ Single safety evaluation studies and tests that meet the international and domestic GLP standards, including safety pharmacology core battery - central nervous system (FOB, Irwin), respiratory system, cardiovascular system (conscious dog and cynomolgus monkey, JET and implant system); microscopic slide preparation and diagnostics, bone marrow smear preparation and diagnostics; macromolecular and small molecular drugs bioanalysis and PK/TK method development, validation, detection and reporting; tissue cross-reactivity, immunotoxicity, immunogenicity, etc. of macromolecule drugs.
◆ Consulting and training for verification of computerized information technology systems and computerized experimental data automatic collection systems that meet international GLP requirements; international/domestic GLP regulatory compliance auditing and consulting.
Copyright © AnLing Biomed (Suzhou) Co., Ltd. All Rights Reserved Source:Boooming ICP:粤ICP备2022021434号-2 CNZZ