Confirm program needs
Review product requirements, patient program details, destination market, and documentation needs.
Therapeutic Areas
Orphan Drugs & Rare Disease
Source hard-to-access orphan drugs and niche therapies for named-patient programs, institutional pathways, and rare disease populations.
Orphan drugs and rare disease therapies are often low-volume, limited-availability products that require specialized procurement — not catalog ordering. McHade helps international partners source hard-to-access therapies through licensed US wholesaler channels with the documentation regulatory teams expect.
Programs span named-patient and compassionate-use pathways, institutional supply for rare disease populations, and niche commercial distribution where product availability is constrained. Each engagement is scoped to the product, program requirements, and destination market documentation needs.
Orphan and rare disease sourcing integrates with McHade named-patient procurement, clinical trial supply, and export services as your program requires — each capability can be scoped and engaged independently.
Who it's for
Built for partners sourcing low-volume, limited-availability therapies
- Patient access programsCoordinate named-patient and compassionate-use sourcing with compliant documentation.
- Rare disease distributorsAccess low-volume orphan products through documented US wholesaler channels.
- Physician & hospital networksSupport urgent unmet needs with export-ready procurement pathways.
What's covered
Scope and capabilities
- Hard-to-access orphan drug procurement pathways
- Named patient and targeted treatment program support
- Compliant documentation from source through export handoff
- Batch-level records for program audit and regulatory review
- Export paperwork, COO, and COA where destination markets require them
- Coordination with named-patient sourcing and clinical trial services as needed
How it works
How McHade supports orphan & rare disease programs
A clear operating path from program scoping through documented cross-border delivery.
Qualify availability
Identify licensed US supply channels and assess product availability against program timeline.
Procure & document
Source with batch records and compile export documentation for regulatory and program review.
Deliver & coordinate
Coordinate shipment with your clearing agent and provide documentation for program teams.
Discuss Orphan Drugs & Rare Disease
Share your orphan drug requirements, patient program details, destination markets, and documentation needs. Our team will review the scope and respond with a compliant sourcing approach — turnaround depends on product complexity and market requirements.