Managed Access Programme — Corex Logistics

What Are Managed Access Programmes?

Managed Access Programmes encompass various regulatory pathways that provide access to medicines before they receive full marketing authorisation:

Structured access pathways for investigational or unlicensed medicines
Regulatory frameworks designed for serious, life-threatening, or rare conditions
Ethical oversight ensuring patient safety and appropriate use
Documentation requirements for regulatory compliance and safety monitoring
Multi-stakeholder coordination between manufacturers, physicians, and regulators

These programmes bridge the gap between clinical development and commercial availability, providing hope when approved alternatives don't exist.

How it works

We establish regulatory frameworks with pharmaceutical partners, implement ethical oversight protocols, and manage end-to-end distribution logistics across multiple European markets.

Problem:

Standard treatments prove insufficient and patients need structured access to investigational medicines

Solution

Managed Access Programmes provide regulatory pathways for structured access before full marketing authorisation.

How COREX Supports Managed Access Implementation

We provide comprehensive operational support across all managed access pathways:

Programme Strategy & Pathway Selection

Expert guidance on the most appropriate access route for your product and patient population

Regulatory Consultation & Compliance

Navigation of country-specific requirements and regulatory submissions

Product Sourcing & Importation

Secure procurement and customs clearance of unlicensed medicines

GxP-Compliant Storage & Distribution

Temperature-controlled logistics with full chain of custody

Documentation Management

Complete regulatory documentation, safety reporting, and audit trail maintenance

Multi-Country Coordination

Harmonised programme implementation across multiple jurisdictions

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When to Consider Managed Access Programmes

Patients face serious, life-threatening, or severely debilitating conditions

No approved treatment alternatives are available in the patient's country

The investigational product has demonstrated efficacy in clinical trials

Regulatory approval is pending or delayed in key markets

There's a clinical need to bridge the gap between trial completion and commercial launch

COREX Global Network

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

Explore our network

Why choose COREX
for Managed Access Support?

Deep experience across all managed access pathways

from individual Named Patient requests to large-scale Early Access Programmes, with proven success in complex therapeutic areas.

Full adherence to international ethical guidelines and local regulatory requirements,

with robust quality systems designed for regulatory inspection readiness.

Established partnerships across the CIS, EU, and UK

enable seamless programme implementation with local compliance expertise and regulatory authority relationships in each market.

24/7 emergency support

Understanding the urgency of patient needs, we provide compassionate, efficient service with 24/7 emergency support and accelerated processing for time-critical cases.

Dedicated project managers

coordinate all aspects from programme setup through patient treatment, ensuring seamless communication between all stakeholders throughout the access journey.

Trusted by global pharmaceutical companies

to execute managed access programmes ethically, efficiently, and in full compliance with international standards.

What Is A Managed Access Programme?

Understanding the Differences in Managed Access Programs

What Are Managed Access Programmes?