The Chemical, Manufacturing, and Control (CMC) section of New Drug Applications (INDs) and Abbreviated New Drug Applications (ANDAs) is required to contain complete chemical and physical characterization of an active pharmaceutical ingredient (API). Chemfocus can help you gather and interpret all the data needed for a CMC section.

We have experience with the necessary analytical techniques and their use in both qualitative and quantitative modes, including NMR spectroscopy (solution and solid), mass spectrometry, infrared and Raman spectroscopy, x-ray analyses (powder and single-crystal), differential scanning calorimetry, thermogravimetry, microscopy, dynamic vapor sorption, particle sizing, and others.