Ensuring Reliable API Crystallization Across Clinical Phases with Expertise”
Controlling and understanding your API’s crystal forms is critical not only in the early Phase of pre-clinical manufacturing but also including later phases of clinical trial manufacturing to commercialization. When new crystal forms appear of clinical trial manufacturing batches (CTM) the FDA will require prior to approval that the process can be controlled to only produce the desired polymorph. We provide the expertise to ensure each and every API manufacturing program will provide reliability and reproducibility in every CTM produced. Our partners have unsurpassed world-renowned leading scientific staff that will ensure your API program will be successful.
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