Identify the product
Confirm the newly approved product, therapeutic area, volumes, and destination market requirements.
Global Sourcing & Procurement
Newly FDA-Approved Products
Access newly FDA-approved US pharmaceutical innovations early — through a registered wholesaler with documentation-ready sourcing for international partners.
New US approvals create competitive windows for international distributors and specialty partners who can move quickly. McHade provides early access to newly FDA-approved products across priority therapeutic areas through licensed wholesaler channels.
Sourcing includes the documentation international partners need for regulatory filing and market entry — batch records, export paperwork, and supporting certificates where destination markets require them.
New approval sourcing complements tender support and named-patient programs — or stands alone when your market strategy depends on being among the first to offer a newly approved therapy.
Who it's for
Built for partners who need first-to-market access
- International distributorsBring newly approved US therapies to your market ahead of competitors with documented supply.
- Specialty pharmaceutical partnersAccess innovations in oncology, biologics, and rare disease through a registered US wholesaler.
- Regional market entrantsBuild product portfolios around the latest FDA approvals with compliant sourcing support.
What's included
Scope and deliverables
- Early access to newly approved US innovations
- Wholesaler network access across priority therapeutic areas
- Documentation-ready sourcing for international partners
- Batch records and chain-of-custody for regulatory filing
- Export paperwork, COO, and COA where destination markets require them
- Coordination with warehousing, cold-chain, and export services as needed
How it works
How McHade delivers this service
A clear operating path from requirements review through documented cross-border delivery.
Qualify supply channels
Locate licensed US availability and assess lead times against your market entry timeline.
Source & document
Procure with batch records and prepare export documentation for regulatory handoff.
Release & coordinate
Coordinate cross-border delivery with your clearing agent and local distribution partners.
US Market Access
Regulatory and documentation support that simplifies compliant entry into and out of the US market.
Quality & GDP
Operational quality controls with GDP-aligned storage, handling, and transportation procedures.
DSCSA
Full DSCSA pedigree support and traceability standards across every shipment.
Discuss Newly FDA-Approved Products
Share your product requirements, volumes, and destination markets. Our team will review the scope and respond with a compliant procurement approach — turnaround depends on product complexity and market requirements.