Our experts always pursue a science-based approach in addressing regulatory issues. Our scientists have developed end-of-Phase-II packages, established sameness protocols to support post-approval supplements, designed protocols for testing for changes (usually stability related) in drug substance and drug product and assisted companies with regulatory compliance issues.
Our deep understanding of the process steps and critical variables enables us to develop forward-thinking strategies, appropriate specifications and robust quality control packages for drug substance and drug product.
Chemistry, Manufacturing and Controls (CMC) Meetings
A successful end-of-Phase-II CMC meeting is critical for the rapid development of your drug. We provide expert problem solving and laboratory work on all aspects of your CMC program. Our solutions will help you prepare for this meeting to help speed your drug to market and avoid costly bioequivalence and bridging studies.
We also provide assistance with CMC issues in the IND phase. It is critical to do clinical trials with the same drug substance and drug product to avoid distortions and errors in the toxicology. We can provide complete IND packages for drug substances including solid form selection, proof of structure, stability of drug substance and drug product, method development, impurity profiling, determination of absolute configuration and packaging.