Assess market requirements
Confirm US operational needs, product profile, destination markets, and documentation expectations.
Compliance
US Market Access
Regulatory and documentation support for entering, operating in, and exporting from the US pharmaceutical market through a registered wholesaler.
Accessing the US pharmaceutical market requires more than product availability — it demands a documented US operational base, wholesaler registration, and export-ready paperwork. McHade provides market access support from a licensed facility registered with the FDA as a 3PL wholesaler.
Whether you need a US address for storage and fulfillment, FDA-aligned export documentation, or a registered partner for international transfer, McHade acts as your documented wholesaler — not a generic logistics broker.
US market access support integrates with McHade warehousing, cold-chain, and DSCSA pedigree services — engage what your program requires independently or together.
Who it's for
Built for international partners navigating US market requirements
- International manufacturersEstablish a compliant US operational base without building your own infrastructure.
- Global distributors & vendorsSource FDA-approved products with export documentation aligned to destination markets.
- Government & hospital vendorsSupport institutional programs with US-licensed supply and cross-border documentation.
What's covered
Scope and requirements
- Licensed US operational base
- FDA-registered 3PL wholesaler for pharmaceutical distribution
- Export paperwork, COO, and COA where destination markets require them
- DSCSA pedigree support on outbound shipments
- Coordination with your clearing agent at destination handoff
- Integration with warehousing and cold-chain services as needed
How it works
How McHade supports US market access
A clear operating path from market assessment through documented cross-border transfer.
Establish US presence
Define warehousing, fulfillment, and wholesaler workflows aligned to your regulatory strategy.
Operate compliantly
Store, handle, and fulfill under licensed wholesaler procedures with full documentation.
Export & transfer
Prepare export packages and coordinate cross-border delivery with your local distribution partners.
Discuss US Market Access
Share your US operational needs, product profile, destination markets, and documentation requirements. Our team will review the scope and respond with a compliant approach — turnaround depends on product complexity and market requirements.