Regulatory Requirements for 12-Month Long-Term Stability Data in Product Registration
Regulatory Requirements for 12-Month Long-Term Stability Data in Product Registration Meeting Regulatory Requirements for 12-Month Long-Term Stability Data in Product Registration Long-term stability data is a fundamental requirement for the successful registration of pharmaceutical products across global markets. While initial submissions may sometimes rely on shorter-term data, most major regulatory agencies—including the FDA, EMA, and…
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