API CRYSTALLIZATION ACROSS CLINICAL PHASES

Controlling and understanding your Active Pharmaceutical Ingredient’s (API) crystal forms is crucial not only during the early phase of pre-clinical manufacturing but also throughout later phases of clinical trial manufacturing and commercialization. The appearance of new crystal forms in clinical trial manufacturing batches (CTM) necessitates FDA approval, requiring evidence that the process can consistently produce the desired polymorph.

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We offer the expertise to ensure every API manufacturing program delivers reliability and reproducibility in every CTM produced. Our partners boast world-renowned scientific staff with unmatched expertise, guaranteeing your API program’s success. With our comprehensive approach, we provide:

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• Early Phase Expertise: We ensure optimal control of API crystal forms from the initial stages of pre-clinical development.

• Clinical Phase Consistency: Our methods guarantee consistent production of the desired polymorph throughout clinical trials.

• Regulatory Compliance: We provide the necessary documentation and process control to meet FDA requirements and secure approval.

• Advanced Scientific Support: Leveraging the skills of our leading scientific team, we ensure that your API crystallization process is robust and scalable.
   

By partnering with us, you can be confident that your API crystallization process is in expert hands, ensuring success from pre-clinical stages to full commercialization.