We employ our powerful analytical method development capabilities to determine the solid form(s) of the active drug in formulations and the stability of the drug product and formulation. Most structural changes produced in the formulation process or occurring during storage can be detected and eliminated and the process improved. This is crucial when troubleshooting problems with dosage forms. We routinely develop full quantitative and limit test assays under cGMP to monitor the solid form in drug substances and drug products. We also issue certificates of analysis for lot release on both the drug product and drug substance. We are a leader in developing and analyzing amorphous formulations for enhanced solubility.