Tag: CTD Module 3.2.P.8

Regulatory Expectations for Accelerated Stability Testing Submissions

Regulatory Expectations for Accelerated Stability Testing Submissions Submitting Accelerated Stability Testing Data: Regulatory Expectations Explained Accelerated stability testing is a vital component of pharmaceutical submissions, especially during early-phase development, technology transfers, and shelf life justifications. Understanding what global regulatory bodies expect in accelerated stability submissions can ensure faster approvals, fewer queries, and greater confidence in…

Real-Time and Accelerated Stability Studies, Stability Testing Types

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…

Intermediate and Long-Term Stability Testing, Stability Testing Types