A Managed Access Program (MAP) is a structured, compliant way for a manufacturer to make an investigational or unlicensed medicine available to patients who have no suitable approved alternative — outside of a clinical trial and, in most cases, before or beyond a standard marketing authorization. GNH USA is a US-based, WHO GDP-certified distributor that partners with pharmaceutical sponsors to operationalize these programs worldwide: sourcing and importing product, managing quality and cold-chain logistics, and supporting the documentation that each market's access framework requires. Sponsors set the medical and regulatory policy; we make the supply work.
Program types
The access frameworks we support
Pre-approval / expanded access
Before a product holds marketing authorization in a given market, defined pathways may allow supply to patients with serious or life-threatening conditions and no satisfactory alternative. These programs sit alongside, not within, the clinical development plan.
Compassionate use
A widely used term for supplying an unapproved medicine to patients on humanitarian grounds. The exact mechanism, eligibility and conditions are set by each country's regulator, so a global program is really a coordinated set of country-level pathways.
Post-approval access
Even after approval, gaps remain — a product may be authorized in some markets but not others, or be temporarily unavailable in a patient's home country. Post-approval access programs and named-patient import help bridge those gaps.
Named-patient supply
Supply directed at a specific, identified patient on a prescriber's request. This individualized route is documentation-driven and well suited to rare-disease and orphan medicines. Learn more about our /services/name-patient-supply.
Cohort programs
Where many patients share the same indication, a cohort program supplies a defined group under common protocols and conditions rather than handling each request in isolation — useful for scaling access while keeping governance consistent.
Early access programs
Some regulators operate formal early access designations that allow eligible patients to receive a promising medicine ahead of full authorization, under defined safety and reporting conditions.
Our role for sponsors
The operational backbone of your access program
Worldwide reach
We source from and ship to regulator-approved markets across the globe, helping a single program serve patients in multiple countries.
Sourcing and feasibility
We help assess where and how product can be obtained or moved for each target market, flagging supply constraints early.
WHO GDP-certified
Procurement, storage and handling follow Good Distribution Practice, protecting product integrity from origin to patient.
Validated cold chain
Temperature-sensitive medicines move through monitored, validated lanes designed to maintain the cold chain end to end.
Import and QA
We coordinate import requirements and quality checks so each shipment is accompanied by the documentation a market's pathway calls for.
Sponsor-aligned governance
We operate within the sponsor's program rules and reporting expectations, keeping medical and regulatory decisions firmly with the manufacturer.
How it works
From program design to patient delivery
- Step 01
Design and feasibility
We work with the sponsor to map target markets, applicable access pathways and supply constraints, then shape the logistics model for the program.
- Step 02
Sourcing
We identify suitable regulator-approved sources and confirm availability for each market the program will serve.
- Step 03
Import and QA
Product is procured and prepared for import, with quality checks and documentation aligned to each destination's requirements.
- Step 04
Distribution
After internal QA, medicines ship through validated, GDP-compliant lanes — including cold chain where needed — to pharmacies, sites or patients.
- Step 05
Reporting
We provide supply and shipment records that support the sponsor's program oversight, pharmacovigilance handling and regulatory reporting.
Talk to us
Design or scale a managed access program
The sponsor sets the policy
GNH USA does not make medical or regulatory decisions about who receives a medicine or under what conditions. Eligibility, protocols and pharmacovigilance remain with the sponsor and treating clinicians. Our focus is compliant supply — sourcing, import, quality handling and distribution — under WHO GDP and each market's requirements.
Discuss a program
Questions
Managed access programs — FAQs
FAQ
Frequently asked questions
What is a managed access program?
A managed access program (MAP) is a structured way for a manufacturer to supply an investigational or unlicensed medicine to patients with serious conditions and no suitable approved alternative, outside of a clinical trial. It is often used before a product is authorized in a market, and sometimes after approval to bridge availability gaps. The exact rules are set by each country's regulator.
How does expanded access differ from compassionate use?
The two terms overlap and are often used interchangeably. Both describe routes for supplying an unapproved medicine to patients who need it on a non-trial basis. Different regulators use different names and conditions, so a worldwide program is usually a coordinated set of country-level pathways rather than a single global mechanism.
What is the difference between named-patient and cohort programs?
A named-patient program supplies a specific, identified patient on a prescriber's request and is highly individualized. A cohort program supplies a defined group of patients sharing the same indication under common protocols and conditions, which makes it easier to scale access while keeping governance consistent.
What does GNH USA actually do in an access program?
GNH USA is the supply partner. We help with feasibility and sourcing, coordinate import and quality assurance, run validated cold-chain logistics where needed, and provide shipment documentation and records. We operate under WHO GDP and within the sponsor's program rules.
Can a single program reach patients in several countries?
Yes. GNH USA is US-based and works worldwide, sourcing from and shipping to regulator-approved markets. Because access conditions differ by country, multi-market programs are managed as coordinated country-level supply, each meeting its own requirements.
Who is responsible for regulatory and medical decisions?
The sponsor and the treating clinicians are. Decisions on eligibility, protocols, safety reporting and pharmacovigilance stay with them. GNH USA does not make those decisions; we handle compliant sourcing, import, QA and distribution to support the program.
Related
Other services
Comparator Sourcing for Clinical Trials
Reference-listed drug and active comparator supply for clinical trials worldwide — direct from manufacturer, with WHO GDP-compliant logistics.
Clinical Trials Supply
End-to-end IMP sourcing, kitting and depot-to-site logistics — GDP-compliant warehousing, manufacturer relationships and a full source-to-site audit trail.
Validated Cold Chain Shipment
WHO GDP-validated cold-chain shipping for biologics, vaccines and temperature-sensitive medicines — qualified boxes and en-route temperature monitoring.