Stay ahead with X Pharma Plus lifecycle management expertise, ensuring your medicinal products remain compliant and competitive. We manage change control, post-approval submissions, risk assessments, and manufacturing site registrations, providing seamless support throughout the product lifecycle.
Post-Approval/Lifecycle Management – Overview
Effective management of post-approval changes is critical to maintaining the compliance and market competitiveness of registered medicinal products. Health Authorities (HAs) require that any modifications to the approved drug product—ranging from formulation changes to manufacturing site updates—be carefully assessed and submitted for approval prior to implementation.
X Pharma Plus offers comprehensive post-approval and lifecycle management services, ensuring registered products remain compliant throughout their lifecycle. Our experts guide you through the whole process—from change control evaluation and submission strategy to the preparation and submission of variation packages, helping navigate the complexities of Regulatory post-approval requirements.
Our services include:
- Change Control Evaluation and Submission Strategy
- Lifecycle Management/Post-Approval Change Submissions
- Nitrosamine Impurity Risk Assessment Submissions
- Manufacturing Site Registration
Post-Approval/Lifecycle Management
“Post-Approval/Lifecycle Management involves managing regulatory updates, variations, renewals, and compliance activities to maintain product approval and market availability.”
Post-Approval Change Submissions
Ensure seamless post-approval submissions and maintain Regulatory compliance with our expert strategies.
Nitrosamine Impurity Risk Assessment
Rely on our specialized expertise to address nitrosamine risk assessment requirements effectively.
Lifecycle Management
Accelerate product compliance and optimization with our expert CMC lifecycle management solutions.