Licensing
Licensed Pharmacies
Licensed facility providing a documented US operational base for international partners.
Compliance
Compliance and quality standards behind every shipment
Compliance is core to every McHade transaction. From DSCSA pedigree and GDP-aligned handling to US market access documentation, international partners get the traceability and quality frameworks regulatory teams expect.
Standards
Three frameworks that support every McHade operation
Each standard addresses a distinct compliance requirement. Explore the framework relevant to your program — then dive into the full detail page.
DSCSA
Full DSCSA pedigree support and traceability standards across every shipment.
The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical distributors to maintain transaction history and transaction information — collectively, the pedigree — for products moving through the US supply chain. McHade provides full DSCSA pedigree support on outbound shipments from a registered US wholesaler.
Explore standardQuality & GDP
Operational quality controls with GDP-aligned storage, handling, and transportation procedures.
Good Distribution Practice (GDP) standards govern how pharmaceutical products are stored, handled, and transported to protect quality and integrity. McHade aligns warehousing, fulfillment, and cold-chain operations to GDP practices your QA team can document.
Explore standardUS Market Access
Regulatory and documentation support that simplifies compliant entry into and out of the US market.
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.
Explore standardOperational backbone
What underpins every compliance standard
The licensing, registration, and documentation infrastructure behind McHade operations — without building it yourself.
Registration
FDA-Registered 3PL
Wholesaler registration aligned to pharmaceutical distribution standards.
Traceability
Full DSCSA Pedigree
Shipment-level traceability across every movement and handoff.
Documentation
Export-Ready Paperwork
Batch records and cross-border documentation for international partner programs.
Discuss your compliance and documentation requirements
Share your product profile, destination markets, and regulatory expectations. Our team will review the scope and respond with a compliant approach — turnaround depends on product complexity and market requirements.