Review the protocol
Confirm comparator or RLD requirements, batch specifications, volumes, and delivery timeline with your team.
Clinical Trial Supply
Comparator & RLD Sourcing
Procure US-licensed reference listed drugs and comparators with batch-specific documentation from a registered pharmaceutical wholesaler.
Comparator and reference listed drug (RLD) sourcing is often the first operational hurdle in a US-linked clinical program. McHade procures FDA-approved products through licensed US wholesaler channels, with batch-level documentation your QA and regulatory teams can file.
Whether your protocol requires a specific RLD, a licensed comparator, or batch-matched supply for a bioequivalence study, McHade coordinates sourcing aligned to your study design — not a generic catalog order.
Comparator and RLD sourcing can be engaged on its own or combined with biologic sourcing and rescue support as your protocol evolves. Each service is scoped independently to your trial requirements.
Who it's for
Built for study teams that need documented US sourcing
- CROs & study managersSecure comparators and RLDs with the batch documentation CRO quality teams require.
- Sponsors & protocol ownersMaintain study continuity with US-licensed supply aligned to your regulatory filing strategy.
- Clinical supply coordinatorsSource specific batches and product configurations without building in-house wholesaler relationships.
What's included
Scope and deliverables
- US-licensed reference listed drugs and comparators
- Batch-specific documentation for regulated studies
- Chain-of-custody support through wholesaler channels
- Sourcing aligned to protocol and study design requirements
- Coordination with biologic and rescue sourcing as needed
- Documentation-ready handoff for sponsor and CRO QA teams
How it works
How McHade delivers this service
A clear operating path from protocol review through documented delivery to your study team.
Qualify the product
Identify licensed US supply channels and verify product availability against protocol needs.
Procure & document
Source the product with batch-level records and chain-of-custody documentation for QA review.
Deliver & hand off
Coordinate shipment to your study depot or site with documentation packages for trial teams.
DSCSA
Full DSCSA pedigree support and traceability standards across every shipment.
Quality & GDP
Operational quality controls with GDP-aligned storage, handling, and transportation procedures.
US Market Access
Regulatory and documentation support that simplifies compliant entry into and out of the US market.
Discuss Comparator & RLD Sourcing
Share your protocol, comparator needs, product profile, and timeline. Our team will review the scope and respond with a compliant sourcing approach — turnaround depends on product complexity and regulatory requirements.