Analytical Testing Services for Clinical Trials
We offer analytical testing services for drugs, including method development, analytical validation, HPLC-MS analysis, impurity profiling, stability studies, and batch release. Our CDMO services are particularly oriented to early-phase clinical trials.
Analytical Testing Capabilities
Through our partners we offer analytical method development and validation for API, drug products, and cosmetic products. We also perform HPLC-MS testing and impurity identification, isolation, and characterization.
We conduct stability testing for API and drug products including: preliminary chemical stability tests (early stage), temperature and humidity controlled stability protocols, excipient compatibility, stress studies (forced degradation), photo-stability studies, extractables and leachables in packaging materials, and in-use stability studies.
Our batch release services include: API supplier and drug product manufacturer audits to ensure GMP compliance, imports into the European Union for drug products manufactured in non-EU member states, Qualified Person verification of manufacturing records, issuance of QP declarations, as well as batch testing, certification and release.