About Us
Gateway Checker
Gateway Checker™ is a Software as a Service offering established to unambiguously assess and verify the readiness of one system to connect and exchange electronic product code information with another. Drug manufacturers, repackagers, and distributors can test, validate, and certify adherence to GS1 US Rx EPCIS. 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.
“Compared to our previous service provider, the Gateway Checker MedTracker™ and TraceReady™ applications make it much easier to view and address EPCIS file issues. These applications make conformance issues easy to diagnose, easy to understand, and easy to fix. Gateway Checker makes our lives so much easier.”
Greg Coombe
Director of Compliance, Oak Drugs
“Since implementing Gateway Checker, we have seen an improvement in our compliance processes… The tool’s reliability and ease of use have made a positive impact on our team’s efficiency to communicate to our customers when there are EPCIS discrepancies.”
Elkin Quizena
Sr. Systems Analyst, Padagis
“Gateway Checker’s expertise in pharmaceutical traceability is truly remarkable, earning our trust and admiration. Their responsive team and technological prowess make them a standout partner in the industry.”
Elijah Kohn
Compliance Manager, NDC Distributors
“Gateway Checker is an excellent tool to ensure that data files are meeting the requirements of GS1 and DSCSA standards and that the data and the physical drug product match, thus avoiding an interruption in the drug supply.”
Ann Schaefer
Former Executive Director, Head of Supply Chain, BioXcel Therapeutics
“The Gateway Checker applications quickly identified significant issues that more than demonstrated the value of their service. They more than earned their fee, delivering a positive return on investment.”
Herb Wong
SVP Product & Strategy, Antares Vision (rfxcel)
“…Gateway Checker is the best tool for us to be able to validate our EPCIS files are conformant … Gateway Certified significantly minimizes conflicts when we start sending data to our customers …”
Scott Mooney
Vice President of Distribution Operations, McKesson
“The Gateway Conformance Testing application provides unparalleled insight into traceability … It is a wonderful tool; it won’t let any bad file get out …”
Vasudeva Saladi
Secure Supply Chain Lead, Cencora
“Partnering with Gateway Checker allows our customers the functionality needed to meet the DSCSA requirements at an affordable cost… they have been a great company to work with.”
Mark Canes
President, Blue Link ERP
Developed by BrandSure
The Gateway Checker™ service was developed in 2017 by BrandSure, after assisting with the creation of the GS1 EPCIS Implementation Guidelines for US DSCSA Traceability.
BrandSure partners with clients to ensure the safety and security of medicines, medical devices and food. We have successfully managed more than 35 serialization-focused engagements, many of them facilitating drug and medical device regulatory compliance. Secure, robust, agile and regulatory compliant supply chains ensure market success.
We have experience deploying solutions from inception to production, which protect millions of units from counterfeiting, gray market diversion, tampering, and fraudulent reimbursement. Our supply chain integrity solutions leverage real-world expertise in brand protection, product packaging, distribution and information management systems.
We deliver: Susceptibility Assessments, Compliance Readiness Planning, Requirements Definition, and oversee Item-Level Serialization and Secure Distribution deployments including EPCIS Conformance Verification, development of Standardized Operating Procedures and Computer System Validation.
BrandSure is a member of HDA and GS1 US Healthcare. We are a GS1 Solution Partner, a GS1 Certified Conformance Testing Service, and an active supporter of GS1 interoperability standards.
