GLP Safety Studies
GLP Safety Studies
・General toxicity, multiple dose toxicology studies, genotoxicity, development and reproduction toxicology
・Efficacy pharmacology, safety pharmacology, PK/PD/drug metabolism studies
・Hemocompatibility test
・Sensitization test
・Irritation test
・Pyrogen test
・Implantation test
・Carcinogenicity test
※ Please inquire about the full range of tests available.
Safety Study Services
The preclinical CRO study center is structured with well-experienced toxicologists, histopathologists and experimental animal care groups, and all studies are conducted under GLP compliance and independent QAU inspection. Furthermore, all study protocols are designed to meet the regulations of each country where clinical trials and marketing of drugs are conducted.
The CRO has succeeded in many IND studies and is recognized by the US FDA as a reliable testing center.
SPF animal rooms
The CRO has the largest number of SPF animal rooms in Taiwan, and received the international AAALAC certification in 2007.
All areas in the facility are designed to have the required environment for conduction of consignment studies. The administration and use of experimental animals are performed in compliance with The Animal Protection Law and The Guideline for the Care and Use of Laboratory Animals.
SPF barrier system
Automatic monitoring system for maintaining animals’ environment
Constant monitoring of animal health
The CRO provides services under the GLP compliance by experts.
|
Test
substance |
Study items |
Compliance with guidelines |
|
Pharmaceuticals
Biosimilar |
・Toxicology ・Safety pharmacology ・Development & reproductive tox |
ICH |
| Medical devices | ・Compatibility test | ISO 10993 |
| Chemicals | ・Toxicological evaluation |
OECD OPPTS |
We propose suitable studies that meet client needs, all conducted by our experts highly-experienced in drug research and development. Please contact us from our “Contact page”.
