Submitting post-approval changes for approved drug products is essential for maintaining compliance and effectively managing the lifecycle of your application. At Agilix, we understand the importance of adhering to regulatory requirements for any changes made to the registered drug product.

Our services for managing post-approval changes include:

• Change Evaluation and Submission: We ensure that all proposed changes to the approved drug product – whether related to formulation, manufacturing processes, labeling, or other aspects – are accurately documented and submitted to the relevant regulatory authorities in accordance with regulatory requirements. We support all post approval change submissions process for major moderate and minor changes such as PAS/CBE-30/CBE-0, Type IA, Type IAIN, Type II variations, Post NOC changes submissions.

• Product Life Cycle Submissions: We ensure all life cycle submissions like Annual Report, Product Renewals, PADER and PSURs are submitted in compliant to regulatory requirements timely and efficiently.