We offer complete analytical development and validation solutions for NCE clinical formulation, differentiated generic and over-the-counter product development. Our analytical experts possess deep expertise in drug product analytical methods for wide range of dosage forms.
We offer comprehensive analytical development and validation solutions for NCE clinical formulation, differentiated generic and over-the-counter product development. Our analytical specialists possess extensive knowledge in drug product analytical methods for a broad spectrum of dosage forms. Our drug product analytical development and validation services encompass the adaptation of drug substance/API methods, forced degradation studies, column and mobile phase selection, impurity identification, pre-validation, full validation as per ICH guidelines, and technology transfer to cGMP laboratories. Additionally, our analytical team supports routine formulation development and stability sample analysis.
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