Early Stage Development
This workflow will find the most stable and viable solid form for development, which should ideally be done before GLP Tox batch. Our scientifically designed workflow screens a wide variety of conditions to probe the polymorphic landscape of your API. Conditions are specifically selected in order to generate the thermodynamically most stable solid form as well as metastable forms, hydrates, and solvates if they exist. The conditions for interconversion between different forms are determined. The data collected is interpreted by our ingenious scientists in order to determine the best solid form for clinical development. You are provided with knowledge of your API and confidence moving forward in the next steps of the drug’s development.
Late Stage Development
This service is ideal for late-phase API to provide comprehensive polymorphic landscape for NDA submission and also extended IP coverage to further block generic entry. Our scientifically designed workflow screens an extensive variety of solvents and conditions in order to discover the maximum number of solid forms of your API. Conditions are selected to generate the variety of metastable forms, hydrates, and solvates that may exist. Characterization of each form is performed in order to obtain the required data for regulatory filings. The data collected is also interpreted by our ingenious scientists in order to understand the relationship between the different forms, and the conditions for interconversion between them. You are provided with knowledge of your API and extensive IP protection.