Lexington, MA, April 22, 2025 – Gateway Checker, the industry’s leading independent GS1 Conformance Testing Service, is excited to announce NDC Distributors, an independently owned generic pharmaceutical wholesaler based out of Cranbury, New Jersey, has successfully attained Gateway Certified™ EPCIS Verify™ accreditation.
EPCIS is a GS1 Standard that enables supply chain partners to capture event information about supply chain events (e.g., shipped, received, etc.), and to share that information with their trading partners securely and in near real-time. EPCIS is the only recognized standard by the pharmaceutical industry and recommended by the FDA to enable DSCSA enhanced traceability compliance.
Gateway Checker EPCIS Verify™ provides cloud-based, portal access to EPCIS Conformance Testing, where outbound EPCIS files are loaded, files evaluated, evaluation reports generated, and results retained. Gateway’s GS1 DSCSA EPCIS Conformance Testing Service comprehensively tests, evaluates, and validates conformance to standards. EPCIS file form, structure, content, and selected outbound GS1 Pharmaceutical Traceability Scenario (PTS) are unambiguously assessed.
“Working with Gateway Checker has been a very seamless process,” says Mark Grant, Systems Analyst at NDC Distributors. “Gateway Checker’s internal verification process makes it easy to identify any files with EPCIS exceptions, and their team is always ready to step in and communicate issues with our vendors. We are truly very happy to have Gateway Checker as our EPCIS partner.”
Transactions that successfully meet Gateway Checker EPCIS Verify™ testing requirements are eligible to become Gateway Certified™. When a transaction is Gateway Certified™, trade partners can be confident their data meets industry and regulatory (DSCSA) standards, helping ensure integrity across the entire supply chain.
After successfully meeting strict conformance requirements, NDC Distributors achieved certification for a wholesaler to dispenser pharmaceutical traceability scenario, incorporating a single purchase order and aggregation. NDC Distributor’s Gateway Certification demonstrates their commitment to DSCSA conformance, supply chain integrity, and patient safety.
“The Gateway Certified™ seal exemplifies a steadfast commitment to meeting full DSCSA requirements. In earning the seal, NDC Distributors’ trade partners can be confident the data they receive is both accurate, compliant with DSCSA regulations, and conforms to GS1 application standards,” says Gary Lerner, Founder and President of Gateway Checker. “
As the end of the stabilization period approaches quickly, we encourage manufacturers, distributors, and 3PLs to get certified by the only independent, GS1-certified conformance testing service available today.”
Next Steps
- For more information on EPCIS Verify™, visit this page.
- Contact the Gateway Checker team through this link.
- Media Contact: Bryan – marketing@nullgatewaychecker.com
About Gateway Checker:
Gateway Checker™ is a Software as a Service platform that facilitates product traceability, DSCSA compliance, and unambiguously verifies the interoperability readiness of serialized pharmaceutical transaction records. Drug manufacturers, repackagers, and distributors can quickly and continuously test, validate, and certify adherence to GS1 US Rx EPCIS and VRS product verification application standards. Gateway Checker is certified by the GS1 US RX EPCIS Testing Service Certification Program and is owned and operated by the Gateway Checker Corporation, a wholly owned subsidiary of BrandSure, LLC.
