Map the product path
Confirm product classification, shipment volumes, destination markets, and pedigree requirements with your team.
Compliance
DSCSA
Full DSCSA pedigree support and shipment-level traceability across every McHade storage, handling, and dispatch operation.
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.
Traceability extends across warehousing, cold-chain handling, and export preparation — so international partners receive documented chain-of-custody records their QA and regulatory teams can file, not just a bill of lading.
DSCSA compliance integrates with McHade GDP-aligned operations and export documentation services — each framework supports the others without requiring a single bundled engagement.
Who it's for
Built for partners who need authenticated, traceable supply chains
- International distributorsReceive shipment-level pedigree records aligned to US traceability requirements for cross-border transfer.
- Manufacturers entering the USMaintain documented transaction history through a licensed US wholesaler partner.
- CROs & clinical supply teamsSupport trial and commercial programs with batch-level traceability and pedigree documentation.
What's covered
Scope and requirements
- Full DSCSA pedigree support on outbound shipments
- Transaction history and transaction information for every dispatch
- Shipment-level traceability across storage, handling, and export prep
- Documentation-ready records for partner QA and audit review
- Integration with GDP-aligned warehousing and cold-chain operations
- Coordination with export documentation for international handoff
How it works
How McHade applies DSCSA standards
A clear operating path from product mapping through pedigree documentation at handoff.
Establish traceability
Align receiving, storage, and dispatch procedures to capture transaction history at each handoff.
Generate pedigree records
Compile transaction information and history for each outbound shipment before release.
Transfer & document
Provide pedigree documentation with the shipment for partner QA review and regulatory filing.
Discuss DSCSA
Share your product profile, shipment volumes, destination markets, and traceability requirements. Our team will review the scope and respond with a compliant approach — turnaround depends on product complexity and market requirements.