This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
|Articles|March 22, 2023
CMC Considerations for Successful Early Drug Development (Mar 2023)
Author(s)Catalent
A key hurdle for any drug development program is bringing the drug to clinical studies. Astute companies strategize past this milestone and plan for clinical and regulatory success. Lack of preparation for scale-up activities needed for eventual commercialization can often cause major time delays, increased costs, and a significant amount of rework. This eBook provides insights on key approaches and considerations for preparing your program for long-term success.
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