Analysis and testing
We provide a One-stop service for contract drug manufacturing and technology development support
We are in a position to offer performing highly advanced laboratory analysis to help our customers in manufacturing high-quality products based on the global standard quality management system.
Our analysis services encompass a wide range of analyses that you need based on our corporate quality system inspected and approved by the GMP inspection authorities in Japan, USA, and EU and through our vast experience accumulated to date in pharmaceutical quality control.
We can provide a broad range of services from laboratory works in the early developmental stage to LCM stage to satisfy the needs of our customers.
Contract services for analysis and testing of drug substances and products
Research of analytical technologies and development of test methods
- Designing and development of evaluation and analytical methods for the development of drug substance and product manufacturing processes
- Designing and development of impurity analytical procedures (including highly sensitive methods and microanalysis)
- Development of analysis and evaluation methods for assessing manufacturing environment, manufacturing facilities and equipment, cross contamination potential, etc.
GMP studies and tests and environmental measurements and analyses
- Stability studies: Preparation of stability data to support regulatory submission application
- Quality tests: Physicochemical and microbiological tests compliant with specifications of official requirement
- Establishment of test methods for pharmaceutical products and validation of analytical methods
- Elemental impurity test (ICH-Q3D compliant)
- Drug-Drug interaction test: Preparation of data to support formulation development and as a reference for HCPs
- Surface analysis: Morphological observation, composition analysis, and mapping analysis of micro areas