Contract analytical services
Contract analytical services
We offer wide range of analytical services by adopting robust and validated international methods. Our analytical services support the entire life cycle from early phase drug development, to regulatory submissions and GMP manufacturing, to post marketing analytical testing requirements.
Analytical Method Development and Validation
We offer wide range of analytical method development and validation services We utilize our knowledge of method development on hundreds of products to assist with the development process. We evaluate attributes such as precision, linearity, accuracy and specificity during development to ensure the method is suitable for validation.
Stability and Photostability Storage and Management
This is our key area where most of our clients rely on. With desired and accurate maintenance of temperature and humidity, our chambers are housed in secured areas, continuously monitored by our validated monitoring systems and supported by a fully validated computerized systems.
Leachables and Extractables
Extractables and leachables (E/L) studies are critical to the identification and quantification of harmful leachable impurities which could migrate from pharmaceutical container closure systems, process equipment and packaging to contaminate pharmaceutical products. Our scientists conduct extractables and leachables studies in accordance with regional guidance, Good Manufacturing Practice (GMP).