Compassionate Use Programs
How Can Patients Access Treatments When No Alternatives Exist?
Compassionate Use Programs provide a regulated pathway for patients with serious or immediately life-threatening conditions to access investigational or unlicensed medical products (drugs, biologics, or devices) outside of clinical trials when no comparable alternative therapy exists. These programs enable compliant global access while balancing urgent patient need with regulatory requirements and controlled supply.
This includes managing regulatory submissions, navigating complex country-specific regulatory requirements, and providing end-to-end GxP-compliant logistics, along with secondary labeling and packaging services.
Scenarios to Consider Compassionate Use
Physician requests are received for a product prior to local marketing authorization or where commercial launch of the product may never be pursued.
In a country with trial sites, providing access for patients falling outside a trial’s inclusion / exclusion criteria, or screen-failing a trial.
During the period of a global trial, providing access for patients in countries with no trial sites or patients cannot access trial sites within a country.
Tanner Pharma supports program sponsors with program design and execution.
Not Sure Where to Start?
Explore our Medicine Access 101 guide for patients and HCPs.
Core Services
Pharmacovigilance
Quality Assurance
Supply Chain & Logistics
Program Management
Regulatory Compliance
Program Management
Regulatory Compliance
Pharmacovigilance
Supply Chain & Logistics
Quality Assurance
How We Deliver Access Solutions
Explore real-world examples of how we navigate regulatory, geographic and supply complexities to deliver compliant, global access to essential therapies.