Regulatory Pitfalls to Avoid in International Stability Submissions
Pharmaceutical companies aiming to register products across regions often struggle with regulatory rejections due to errors in stability submissions. Agencies like USFDA, EMA, WHO, and CDSCO enforce nuanced expectations that go beyond ICH guidelines. This article outlines the most frequent regulatory pitfalls encountered in global stability dossiers and offers practical guidance to avoid them. Pitfall…
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