Solid State Chemistry Requirements Throughout CMC Development

Since different polymorphs have different physicochemical properties, identifying a viable polymorph early during the drug development is essential. By end of Phase II, knowledge about the solid state form should be provided to the FDA including the propensity to exhibit polymorphism along with other physicochemical data. Regis can help you through the drug development process by building knowledge about your solid state forms which ultimately can establish robust API/formulation processes, mitigate risks, minimize problems, and ultimately reduce development timelines.

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