The Titanium Chemical, Manufacturing and Control (CMC) team is familiar with various ICH M7 and NMPA regulations and guidelines, owns rich experience in quality study, can provide overall quality study and stability study on various dosage forms of innovative chemical drugs and generic drugs, and can fully support customers' quality study demands for APIs and preparation.
Study on control strategy of genotoxic impurities in APIs and preparations
Ames test evaluation
Method development and validation
Testing of genotoxic impurities in starting materials, intermediates, APIs and preparation products