SSCI has broad and significant experience assisting companies with their regulatory concerns. SSCI has 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.
Through these activities SSCI’s scientists have developed an appreciation for the importance of a science-based approach in successfully addressing regulatory issues. A thorough understanding of the process steps and the critical variables enables SSCI scientists to develop appropriate specifications and a robust quality control package for drug substance and drug product.
The end-of-Phase-II CMC meeting is critical for the rapid development of your drug. For example, the success of Celebrex and Lipitor was attributed to focused meetings with the FDA (The Pink Sheet, February 8, 1999). The goal of the end-of-Phase-II meeting is to establish parameters for Phase III clinical trials and parameters for the CMC section of the NDA. At this meeting the specifications for the drug substance should be discussed and synthetic chemistry and analytical chemistry should be reviewed. The drug product should be described and initial stability and dissolution work summarized. A well-planned program aimed at rapidly gathering the data for this meeting will speed your drug to market and avoid costly bioequivalence and bridging studies. SSCI can provide you with expert problem solving and laboratory work on all aspects of your CMC program.
SSCI also provides assistance with CMC issues in the IND phase. It is critical to do clinical trials with the same drug substance and drug product. If not, the clinical trials and toxicology may be distorted or incorrect. For example, an amorphous form may provide much higher solubility and blood levels for both clinical trials and toxicology than a crystalline material. SSCI can provide complete IND packages for drug substances including solid form selection, proof of structure, stability of drug substance and drug product, methods development, impurity profiling, determination of absolute configuration, packaging, etc.