Pleksus provides comprehensive support for the planning, implementation, and management of Compassionate Use Programs (CUPs), enabling access to investigational or unlicensed treatments for patients. Our services include regulatory submissions, stakeholder and authority coordination, logistics management, safety monitoring, pharmacovigilance activities and program reporting.
- Project Coordination
- Program Application
- Patient Application
- Communication with Health Authorities and Sites
- Periodic Report Submissions
- Program Product Management and Customs Clearance
- Safety Submissions
- Program Closing Report Submission