Gateway Certified™

Share DSCSA Information with Confidence

Gateway Certified Logo, the seal of approval for pharmaceutical supply chain integrity and DSCSA compliance.A “Gateway Certified” drug transaction report enables you to be confident that transactions are compliant, interoperable, and fully conform to industry and regulatory requirements.

The Gateway Certification program leverages Gateway Checker’s TraceReady application for drug transaction quality assurance. Transaction records that pass TraceReady’s rigorous conformance testing requirements are eligible to be Gateway Certified™. The Gateway Certified™ seal of approval means that all trading partners can:

  • Be confident in data quality, ensuring integrity across the entire supply chain, as well as alignment with FDA DSCSA requirements.
  • Quickly understand and address areas of non-conformance to dramatically improve supply chain efficiency and reduce costly exception handling, rework, and reverse logistics.

Certification is available for manufacturers, distributors, wholesalers, and solution providers.

To learn more about the Gateway Certification program, contact us today.

Hear Why the Industry’s Best Trust Gateway Checker

“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.”

Marc Canes

President, Blue Link ERP