Profile
Our state-of-the-art laboratories and clinical testing facilities are equipped with the latest technologies, ensuring accurate and precise results. Our services range from method development and validation, stability studies, QC testing, finished product release testing as well as formulation development and manufacture, clinical testing of your IMP and medical device. We ensure that your products meet regulatory requirements and are safe for human use.
- Quality control testing of raw materials, APIs, and finished products
- Monograph testing (USP, EP, BP, and JP)
- Analytical method development and validation
- Antibody product analysis
- Bioanalysis, mass spectrometry and immunoassays
- Biologics safety testing (endotoxin, virus and mycoplasma)
- Cell-line characterization
- Comparative dissolution Profiling
- Container testing (extractables and leachables)
- Environmental Monitoring
- Glycosylation analysis
- Host-cell impurity testing
- Medical device testing
- Microbiological testing
- Protein/peptide analysis and quantification
- Safety testing (in vitro)
- Stability testing according to ICH/ASEAN guidelines or customer specifications
- Water system validation
