Identifying regulatory and quality priorities for 2024
As we approach the end of 2023, and companies finesse their road maps for 2024, Arriello’s Kate Coleman assesses the multiple priorities vying for attention.
The pharma industry continues to be in a state of flux. Merger and acquisition activity remains rife, new regulatory updates are being rolled out all the time, and companies are still reviewing supply chain security following the pandemic, the ongoing situation in Ukraine and economic uncertainty.
Meanwhile, a whole raft of patents is expiring, triggering a rise in biosimilar manufacture. As new molecules pass through the preclinical stage and move towards clinical trials, developers must consider formal requirements including Quality GxP measures as part of their clinical strategies.
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