This comprehensive case study explores Kymanox’s approach to overcoming limited internal resources and tight timelines for commercializing an extended-release injection product. Our team of SMEs collaborated closely with stakeholders to implement measurable improvements across contract packaging management, project oversight, and regulatory compliance to achieve a successful product launch.
CHALLENGE
SOLUTION
RESULTS
- Support commercialization of an extended-release injection product under tight timelines with limited internal technical and project management resources.
- Manage critical third-party activities such as contract packaging, serialization, batch record reviews, packaging, labeling, shipping, and inventory to ensure a compliant product launch.
- Provided end-to-end technical, quality, and project management resources to deliver project milestones on time and within budgets.
- Directly supervised the Client’s Contract Packaging Organization (CPO), expediting carton and artwork design, eliminating the need for hiring additional staff.
- Managed project schedules, developed Standard Operating Procedures (SOPs) and batch records, sourced packaging materials, and supported serialization and labeling.
- Designed packaging process flows and facilited inventory management to maintain operatinal continuity.
- Enabled the Client to meet tight product launch deadlines by efficiently managing commercialization tasks and resource gaps.
- Supported cost-effective project delivery without requiring additional full-time personnel.
- Delivered a streamlined and well-coordinated commercialization process, ensuring compliance and positioning the product for a successful market entry.