|Articles|March 13, 2023

Establishing and Maintaining Phase-Appropriate Regulatory Starting Materials Designation from Development to Commercial Launch Secures Successful New Drug Development

Author(s)Wuxi

WuXi Sta outlines clear guidance on phase appropriate RSM designation and adaptive RSM strategy for the overall API development roadmap. These solutions will mitigate both quality and regulatory risks, thus increasing the chance of success in IND and NDA filing.


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