Compassionate Use

Compassionate Use

Access to Unapproved Medicines in Urgent
and Life-Threatening Situations

What Is Compassionate Use?

Compassionate Use (also known as Expanded Access in some regions) refers to the provision of a medicine that:

  • Is still under development or awaiting approval
  • Is not commercially available in the patient’s country
  • May offer potential benefit where no alternatives exist
  • Is requested for a specific group of patients or even one individual

These programmes are often authorised by national Ministries of Health or ethics committees, and require strict eligibility and documentation.

How it works

We work alongside manufacturers, treating physicians, and national regulators to ensure Compassionate Use is handled with sensitivity, precision, and full legal alignment.
Problem:
When patients face serious or life-threatening conditions — and no approved treatment is available.
Solution
Compassionate Use Programmes may offer a path forward.
At COREX, we support ethical and compliant access to investigational or unlicensed medicines in cases where time is critical, and options are limited.

How COREX Supports Compassionate Use Supply

Importation & Customs Clearance of Unapproved Medicines

Importation & Customs Clearance of Unapproved Medicines

GxP-Compliant Storage & Temperature-Controlled Delivery

GxP-Compliant Storage & Temperature-Controlled Delivery

Documentation Handling & Regulatory Liaison

Documentation Handling & Regulatory Liaison

Support for Individual or Cohort-Based Access

Support for Individual or Cohort-Based Access

Project Management Aligned With Ethics and Urgency

Project Management Aligned With Ethics and Urgency

COREX Global Network

COREX Global Network

Ensuring seamless clinical supply solutions with local expertise and global reach.

Why choose COREX
for Compassionate Use?

Trusted by pharmaceutical manufacturers and hospitals in high-stakes cases

Trusted by pharmaceutical manufacturers and hospitals in high-stakes cases

Infrastructure to handle cold chain, controlled substances, and fragile stock

Infrastructure to handle cold chain, controlled substances, and fragile stock

Experience managing documentation for urgent authorisations

Experience managing documentation for urgent authorisations

Responsive, multilingual communication with sites and regulators 

Responsive, multilingual communication with sites and regulators