Körber Supply Chain Achieves Gateway Certified® Accreditation

Posted by bryan hanley On March 23, 2026 at 10:48 pm | Comments Closed

Gateway Checker® is excited to announce Körber Consulting has successfully attained Gateway
Certified® EPCIS Verify™ accreditation. A leading global technology group, Körber has been
providing innovative supply chain solutions for decades. As the industry’s leading independent
GS1 Conformance Testing Service, Gateway Checker applauds Körber’s accomplishment, which
demonstrates their commitment to pharmaceutical supply chain integrity, data interoperability,
and overall patient safety.

Koerber and Gateway Checker at the 2026 DMC Conference

Körber Supply Chain Team (Matt Deep, left, and Steve Markham, right) with Gateway Checker
President, Gary Lerner, at the 2026 HDA Distribution Management Conference in Austin, Texas.


Leveraging its TraceReady™ application for drug quality assurance, Gateway Checker launched
the Gateway Certified conformance program after producing files pursuant to the strict GS1 US
Implementation Guideline. By earning the Gateway Certified seal of approval, supply chain
partners can be confident in data quality while providing their customers file integrity
confidence.

“The certification process helped us take a closer look at how our outbound files are structured,
validated, and delivered,” said Sherri Bauman, Quality and Testing Manager at Körber. “This
allows Körber to produce fully conformant files aligned with GS1 standards, highlighting
improvements that support greater consistency and accuracy.”

Bauman added, “This milestone better positions Körber to meet current requirements and adapt more easily to future compliance needs, while supporting smoother data exchange for our partners and customers. This is a foundational step that improves data quality, supports scalability, and reinforces our commitment to standards-based compliance now and in the future.”

“When EPCIS solution providers commit to testing and compliance to interoperability
application standards, like Körber, pharmaceutical supply trade partners benefit,” said Gary
Lerner, President of Gateway Checker Corporation. “As more suppliers follow Körber’s lead,
drug transaction records will flow faster with fewer inaccuracies, minimizing supplier
disruption.”

To learn more about the Gateway Certified program, reach out to our team or visit our
website.

Click here to read the Körber press release.

The Compounding Center Earns Gateway Certified® Accreditation for EPCIS

Posted by bryan hanley On March 20, 2026 at 2:06 pm | Comments Closed

Lexington, MA, March 19th, 2026 – Gateway Checker®, the industry’s leading GS1 Certified Conformance Testing Service, is proud to announce The Compounding Center has achieved Gateway Certified® EPCIS Verify™ accreditation, after creating files conforming to the specific demands of GS1 EPCIS 1.2 DSCSA requirements.  

“Gateway Checker’s GS1 certification and deep expertise haven’t just helped our team, they’ve elevated standards across the entire industry”, said Joel Gomez, President of The Compounding Center. “By leveraging the TraceReady™ platform and becoming Gateway Certified, we’ve not only maintained strict compliance but also reinforced our commitment to safe, reliable distribution for our customers.” 

The Compounding Center is a leading pharmaceutical and medical supply distributor serving more than 3,500 healthcare facilities across 45 different states nationwide; their accreditation demonstrates an outstanding commitment to DSCSA compliance, supply integrity, and patient safety, helping keep data and product moving efficiently to pharmacies and patients downstream. 

Gateway Checker EPCIS Verify is a cloud-based, EPCIS Conformance Testing Platform providing pharmaceutical manufacturers, repackagers, and wholesalers with a complete file assessment solution. As part of Gateway Checker’s Traceability Platform, EPCIS Verify comprehensively tests, evaluates, and validates file conformance to stringent GS1 EPCIS DSCSA requirements.  

With 16 different Pharmaceutical Traceability Scenarios (PTS) to verify against, EPCIS Verify provides users and their customers the confidence that their files are meeting advanced regulatory requirements. This process of continuous quality assurance helps prevent issues of noncompliance, costly rework, and product quarantines, while alleviating the threat of counterfeit product to patients. 

“We appreciate The Compounding Center’s commitment to patient safety, and we admire their sense of urgency to comply,” says Gateway Checker Founder and President, Gary Lerner. “As a team demonstrating consistent, clear communication with Gateway Checker and their supply chain partners, this accreditation illustrates their emphasis on minimizing file delivery complications and ensuring data is delivered safely and in a timely manner.” 

For more information about the Gateway Certified® Program for both EPCIS and VRS, or to discuss more about Gateway Checker’s comprehensive traceability platform, visit our website or contact our team here. Wherever you are in your compliance journey, Gateway Checker is here to help. 

Media Contact – 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 a GS1 Certified Conformance Testing Service and is owned and operated by the Gateway Checker Corporation, a wholly owned subsidiary of BrandSure, LLC. 

US Pharmaceutical Product Verification and VRS – Ready for Prime Time?

Posted by bryan hanley On November 4, 2025 at 12:45 pm | Comments Closed

The Verification Router Service (VRS) can verify the printed product identifier barcode of U.S. prescription pharmaceuticals in about one second. As a result, Authorized Trading Partners (ATPs) can quickly determine whether a returned item is safe to resell or if commerce should be suspended due to recalls, expiration, or suspicion of illegitimacy.

This marks the realization of a 10-year effort. I remember participating in the 2015 HDA Traceability Work Group, wondering whether there was enough interest and esprit de corps to bring this vision to life.

Last Friday (October 24th), I presented on exception handling status codes and their implications alongside other industry leaders at the HDA VRS Quarterly Update. Based on a recent review of over 140,000 verification requests from September 2025, more than 80% of product verification requests are successfully processed, and 95% of those are verified as “True.”

Here’s what the analysis tells us:

  1. Requests are increasing, and there is a 75–80% probability that the product’s GTIN will be found in the VRS directory.
  2. About 5% of successful requests return “Verify = False,” with 75% of these due to a non-matching Product Identifier.
  3. Approximately 15% of GTINs requested are not found in the lookup directory.
  4. A variety of factors—such as unauthorized access, bad requests, and server errors—account for the remaining 5% of verification failures.
  5. Some responders are not faithfully following GS1 Application Standards, and a few solution providers have invented their own verification failure reason codes.

If you’re a pharmaceutical manufacturer or wholesaler, it’s time to fully embrace and adopt VRS. Here’s why:

  1. Under DSCSA, all trading partners must have “verification systems” for managing suspect and illegitimate products.
  2. Successful product verification using VRS is no longer a vision—it’s a reality.
  3. Manufacturers may face a competitive disadvantage if their competitors support VRS and they do not.
  4. ATPs achieve the fastest possible verification with VRS—especially when systems are maintained and manufacturing participation rates reach 95%.
  5. Wholesalers can easily facilitate saleable returns and avoid being caught off guard by recalled or suspect products.
  6. With regulators increasingly recognizing the value of product verification, the supply chain should expect more requests. Not being able to respond is a risk your business can easily avoid.
  7. If you’re struggling to reliably execute or respond to product verification requests, use the VRS test environment to troubleshoot your system.

Gateway VRS Verify can ensure your VRS system is functioning as designed, and help you become Gateway Certified, the industry seal-of-approval demonstrating commitment to DSCSA conformance. To learn more, contact the Gateway Checker team here.

Our recommendations for improving drug product verification:

  • Develop and Communicate Best Practices: Review GS1’s best practices for handling different HTTP status codes and share them with your trade partners to ensure timely and accurate responses. Analyze verification call patterns to identify common efficiency gaps.
  • Establish SOPs: Create step-by-step Standard Operating Procedures for various product verification scenarios. Ensure SOPs are well-documented and staff are properly trained.
  • Performance Monitoring: Continuously monitor your VRS system’s performance, including response times, the percentage of HTTP 200 responses, and the percentage of successful verifications (Verified = True).
  • Update Systems Frequently: Schedule regular updates to address deficiencies that impact output quality and user experience.
  • Test VRS Systems: Test your VRS system under various scenarios (expected vs. observed responses) using an independent, comprehensive testing application like Gateway Checker’s VRS Verify.

With so many solution providers offering different VRS systems, using an independent system provides impartial governance and auditable evidence of your VRS network’s readiness to support accurate product verification.

What are your experiences with VRS? Feel free to let us know by messaging our team: support@nullgatewaychecker.com

Trump’s Tariffs and the Price of Prescription Drugs

Posted by bryan hanley On May 13, 2025 at 7:58 pm | Comments Closed

Money and Pharmaceuticals on a table

Tariffs and the Pharma Supply Chain

The impact of the Trump Administration’s tariffs extends across numerous industries. While the reality of tariffs is yet to hit Finished Pharmaceutical Products (FPPs), the threat has become more and more real. Tariffs on FPPs have largely been avoided over the past decades as a result of the 1994 Pharmaceutical Agreement between the United States, the European Union, China, and a few other participants; the agreement was established to eliminate trade barriers on a large number of pharmaceutical substances.

A few weeks ago, however, the Trump administration proceeded with probes into pharmaceutical imports, setting the stage for potential tariff implementation. The administration has argued these tariffs will incentivize companies to bring production back into the U.S., helping make the supply chain more robust and decreasing the potential for disruptions. A few major pharmaceutical companies have already indicated plans to invest in the U.S. in response to this threat, including Roche, Novartis, AstraZeneca, and Eli Lilly.

Higher Costs, Higher Prices

However, many pharmaceutical leaders have spoken out against tariffs, arguing that tariffs could lead to supply chain disruptions and higher prices. According to Giovanni Barbella, the global head of strategy at Sandoz, because the margins of generic pharmaceuticals are so small, higher production costs stemming from these tariffs would directly increase the prices paid by consumers.

Barbella added that if tariffs further reduce these already tight margins, some players within the pharmaceutical supply chain may elect to leave the U.S. market altogether, instead focusing on more profitable markets. This will threaten the supply of U.S. pharmaceuticals, and in turn, lead to higher prices for drugs that remain in the U.S. as competition subsides.

Ernst & Young analyzed the potential increase in drug costs in the U.S. if tariffs are implemented, and the results are quite significant: a 25% tariff would increase drug costs by almost $51 billion annually. If companies choose to pass these tariffs onto consumers, Americans would be expected to pay 12.9% more (on average) for their prescription medications.

Remain Focused on Compliance

With the DSCSA Deadline just around the corner (May 27th, 2025, for manufacturers), the threat of tariffs and the additional costs associated with them are another added burden. Don’t let the threat of tariffs take away from compliance efforts – the penalties for noncompliance are substantial.

Gateway Checker’s suite of traceability and conformance testing services provides trading partners the confidence that their exchanges meet strict DSCSA requirements, all at a fraction of the cost. With the threat of tariffs and compliance demands on the rise, see how Gateway Checker makes compliance both simple and affordable.

To learn more, contact us or visit our website:

Coming Up Next

Trump’s recent executive order, which gave drugmakers a 30-day deadline for lowering the price of prescription drugs, will likely have a big impact on all stakeholders within the supply chain.

In the coming days, as the dust settles, I will provide some insights on how this legislation may play out alongside potential FPP tariffs.

With tariffs expected to raise prices, and the executive order seeking to lower them, what will the outcome be?

NDC Distributors Earns Gateway Certified™ EPCIS Verify™ Accreditation 

Posted by bryan hanley On April 22, 2025 at 3:28 pm | Comments Closed

NDC Distributors Logo

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 

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.