Based out of South Korea, GemVax is one of the leading pharma research and development organization conductiong R & D for anti-cancer iimunotherapeutic and peptide drugs.
GemVax were in need of safety solution as their products are ready to be marketed. They had a limited understanding of the overall process of implementing a safety systems application. The requirement was to manage the entire project to deliver a fully validated system before marketing of the approved products. The key challenges GemVax faced in preparing to marl‹et their approved products:
- Limited understanding of safety system implementation
- Implementing a fully validated safety system in time to market the drugs
- End-user training to work on the newly implemented system