Post-Approval/Lifecycle Management - Overview
Submission of post-approval changes for the approved medicinal drug products is critical to ensuring the compliance of the registrations and managing the lifecycle of the application. Health authorities (HA) require continuous oversight on any change made/proposed to the registered content of the drug product is submitted and necessary approval is received before implementation as applicable.
At Freyr, we offer a range of post-approval and lifecycle management services to ensure that the registered drug products remain compliant and competitive throughout their lifecycle. From change control assessment, change submission strategy, preparation, and submission of a variation package to ensure approval receipt from HA, our experts provide the support needed to navigate the complexities of Regulatory post-approval and lifecycle management.
Freyr’s lifecycle management services are designed to support the registered drug products in managing these post-approval activities effectively.
Our services include:
- Change Control Evaluation and Submission Strategy
- LCM/ Post-Approval Changes Submissions
- Nitrosamine Impurity Risk Assessment Submissions
- Manufacturing Site Registration
Freyr’s-Post Approval/Lifecycle Management
Post-Approval/Lifecycle Management
- Assessment of changes and Regulatory impact of proposed changes
- Development of Regulatory strategic submission plans to ensure compliance for multiple products with multiple HAs
- Preparation and submission of lifecycle management and post-approval supplements
- Preparation and submission of comprehensive risk assessment reports that involve HA-driven compliance activities
- Management of Regulatory requirements for manufacturing site registrations
- Preparation, review, and submission of variation, supplement, and amendment packages in line with country-specific HA requirements
- Site transfers and changes in MAH, name and address of facilities, and other administrative submissions
- Experts with extensive experience in change control evaluation and submission strategy
- Ensure compliance with HA-specific requirements like pharmacopoeial compliance, nitrosamines, elemental impurities, and genotoxic impurities
- Manufacturing site registration for applicable countries
- Global strategy for applicable changes for impacted products across multiple HAs
- One-stop solution to manage the lifecycle of the drug products for all global HAs
- Industry experts in the change control assessment and preparing strategies
- Scientific/logical justifications to avoid HA queries or rejection
- Experience in handling huge product portfolios of large bio/pharmaceutical and pharmaceutical clients for their lifecycle management
- Multiple resources available to manage volume peaks
- Efficient management of change control assessment and post-approval supplement submissions
- Access to specialized in-house knowledge repository for effective Regulatory maintenance
