Cole and Jaenisch dig into AI poisoning in pharma manufacturing, how it hides in plain sight, and who should be accountable for catching it.
|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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