Lifecycle Management refers to the ongoing process of maintaining, optimizing, and ensuring compliance of a drug or medical product throughout its entire lifecycle from development and approval to post-marketing, variations, and eventual discontinuation. It encompasses regulatory updates, safety monitoring, change management, and continuous improvement to optimize product value and ensure patient safety.
Lifecycle Management – Overview
A Marketing Authorization Holder (MAH) is responsible for maintaining the registered dossier in compliance with country-specific requirements throughout the lifecycle of the pharmaceutical product. Depending on the Health Authority, the MAH must periodically submit Annual Reports (ARs) or Renewal Requests. Global Health Authorities have varying requirements for these submissions, making a well-defined Regulatory submission strategy essential for timely approval and compliance.
X Pharma Plus provides specialized CMC lifecycle management consulting, helping manufacturers efficiently manage Regulatory submissions for approved products. Our expertise ensures that all post-approval activities, including ARs, renewals, and compliance updates, are executed seamlessly across global markets.
Lifecycle Management
“Lifecycle Management ensures continuous compliance, quality, and optimization of a medical product from development through post-approval stages.”