A biopharmaceutical organization was beginning work on commercialization initiatives for an extended-release injection and required support for several areas to ensure a successful outcome. Kymanox was brought in on the project to provide comprehensive technical and project expertise in the following areas: identification, selection, and oversight of 3rd-party contract packaging, serialization oversight, technical reviews (including batch record reviews for lot release), investigations, packaging, and labeling, shipping, and inventory management.
Challenge
The client was faced with short timelines and limited internal technical and project management resources as they prepared to execute critical activities required for commercialization of its extended-release injection product.
Solution
Kymanox provided the client with technical, quality, and project management resources required to achieve the project deliverables required for product launch on-time and within budget.
Results
Kymanox provided direct supervision of the client’s Contract Packaging Organization to deliver the final carton and artwork design for the product’s secondary packaging. This allowed work on the project to happen more quickly and avoid extending the timeline to find a full-time employee to fill this role. Our team also oversaw and managed all timelines to ensure project tasks were completed on time, generated standard operating procedures (SOPs) and batch records, procured packaging materials provided serialization and labeling support, created process flows for packaging, and provided overall inventory management support.