X Pharma Plus simplifies post-approval changes, offering expert Regulatory support for CMC modifications, lifecycle management, and compliance strategies. Ensure your pharmaceutical products meet global standards with our dedicated services.
Post-Approval Change Submissions – Overview
To optimize productivity and control operational costs, medicinal product manufacturers often propose changes to the registered content of their product applications/dossiers. Any modifications to the approved product, including those related to CMC or Post-Approval Regulatory Affairs, must be submitted to the respective Health Authority (HA) according to the appropriate submission procedures, along with supporting data, before implementation. The requirement for prior approval depends on the type and impact of the change, in line with the CMC post-approval change submission guidelines of the respective HAs.
At X Pharma Plus, our CMC Regulatory Affairs team brings extensive experience in managing post-approval change submissions, including supplements, amendments, and CMC variations, tailored to country-specific Regulatory requirements. Additionally, our Regulatory Compliance experts provide comprehensive post-market surveillance, post-approval Regulatory support, lifecycle maintenance, ANDA post-approval changes, and other services to ensure ongoing compliance with global Regulatory standards.
Post-Approval Change Submissions
“Post-Approval Change Submissions are regulatory filings made to health authorities to notify or seek approval for changes to an already approved drug product, process, or labeling.”