Gateway Checker
Gateway Checker is a US-based SaaS platform that tests and certifies pharmaceutical supply chain EPCIS files and VRS systems against GS1 standards for DSCSA compliance, serving manufacturers, distributors, repackagers, and serialization solution providers.
- Company typePrivate
- Founded2019
- HeadquartersLexington, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Gateway Checker does
Gateway Checker Corporation is a privately held US SaaS company (headquartered in Lexington, Massachusetts and governed under Massachusetts law) that provides conformance testing and certification services for pharmaceutical supply chain traceability under the US Drug Supply Chain Security Act (DSCSA). The company operates as a wholly owned subsidiary of BrandSure, LLC and is led by founder and President Gary Lerner. Its platform tests EPCIS files and Verification Router Service (VRS) responses against GS1 standards, evaluates them through the proprietary TraceReady application across 16 Pharmaceutical Traceability Scenarios and seven DSCSA metrics, and issues the Gateway Certified® seal plus GS1 US Trustmarks upon successful conformance.
The product surface is built around three core modules — TraceReady (automated EPCIS conformance scoring), EPCIS Verify (cloud-based GS1 EPCIS DSCSA testing), and VRS Verify (independent VRS conformance testing for product verification systems) — supplemented by an AS2 Connectivity Platform that supports secure file exchange between trading partners. Gateway Checker is the only organization certified by GS1 US as a Conformance Testing Service under the GS1 US Rx EPCIS Testing Service Certification Program, and the Gateway Certified® trademark is registered with the USPTO. The platform integrates with major serialization solution providers (TraceLink, LSPedia, rfxcel, Infinitrak, Advasur) and ERP systems (notably Blue Link ERP).
Revenue is generated through enterprise SaaS subscriptions on an annual billing cadence, conformance testing and certification fees, and professional services for onboarding, test file validation, and nonconformance resolution. Pricing is quote-based and not publicly disclosed. The go-to-market combines direct enterprise sales to pharmaceutical manufacturers, repackagers, wholesale distributors, and dispensers with a channel motion through serialization and ERP partners. Named enterprise references include McKesson Corporation, Blue Link Associates, Movilitas.Cloud, Körber Supply Chain, The Compounding Center, and NDC Distributors. The company is privately funded through its parent and has not disclosed venture capital or institutional investment.
Gateway Checker firmographics
Firmographics- Name
- Gateway Checker
- Legal name
- Gateway Checker Corporation
- Website
- https://gatewaychecker.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Gateway Checker is a US-based SaaS platform that tests and certifies pharmaceutical supply chain EPCIS files and VRS systems against GS1 standards for DSCSA compliance, serving manufacturers, distributors, repackagers, and serialization solution providers.
- Ownership category
- akta.pro rank
Gateway Checker industry classification
Industry- Product category
- Pharmaceutical Supply Chain Compliance Software
- NAICS
- Testing Laboratories and Services (54138)
- SIC
- Services-Testing Laboratories (8734)
- akta.pro primary industry
- Third-Party Traceability Platform Assurance (SOC/ISO-aligned controls for traceability data) (AFALAGAK)
Keywords
Where Gateway Checker is headquartered
LocationHeadquarters
- HQ city
- Lexington
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Gateway Checker business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Operations, Infrastructure, Marketing or Sales
Revenue model
- SaaS Subscription Services: Gateway Checker provides SaaS applications and programmable interfaces on a subscription basis. Drug manufacturers, repackagers, and distributors subscribe to access conformance testing, validation, and certification services for GS1 US Rx EPCIS and VRS product verification application standards.
- Conformance Testing Services: Charges for testing and validating EPCIS file conformance and VRS product verification systems against GS1 standards. Provides certification upon successful completion of conformance scenarios.
- Professional Services: Professional services including onboarding support, trading partner configuration, test file validation, and customer support for nonconformant file resolution.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Enterprise SaaS subscription with conformance testing and certification |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels9 records
Gateway Checker product offering
Product offeringCore offering
Gateway Checker provides SaaS applications and programmable interfaces for testing, validating, and certifying EPCIS file conformance and VRS product verification readiness in pharmaceutical supply chains under FDA DSCSA requirements. Its TraceReady platform performs automated conformance testing across 16 Pharmaceutical Traceability Scenarios, complemented by EPCIS Verify, VRS Verify, and the Gateway Certified accreditation program that issues GS1 US Trustmarks to certified trading partners.
Product overview
Gateway Checker provides a SaaS-based product traceability platform designed specifically for pharmaceutical supply chain DSCSA compliance. The platform is built around the TraceReady application which serves as the core traceability engine, complemented by specialized testing and certification modules including EPCIS Verify for EPCIS file conformance testing and VRS Verify for product verification system testing. The Gateway Certified Program leverages TraceReady to test outbound files under 16 different Pharmaceutical Traceability Scenarios (PTS). The platform integrates with ERP systems like Blue Link ERP and various serialization solution providers (TraceLink, LSPedia, rfxcel, Infinitrak) via AS2 connections to enable seamless EPCIS file exchange between pharmaceutical trading partners.
Differentiator
Problem solved
Functional benefit
Brands
- TraceReady: A traceability readiness application for drug quality assurance that tests outbound EPCIS files under rigorous DSCSA standards.
- Gateway Certified
- VRS Verify
- EPCIS Verify
Products and services
- TraceReady A traceability readiness application that performs automated conformance testing of EPCIS files against 7 DSCSA metrics across 16 Pharmaceutical Traceability Scenarios, scoring files as Pass, Pass with Warnings, Pass with Alerts, or Fail. It enables serialized goods receipt, product verification, reconciliation, inventory management, fulfillment, and conformance certification for pharmaceutical manufacturers, repackagers, and wholesale distributors.
- EPCIS Verify A cloud-based EPCIS Conformance Testing Platform that comprehensively tests, evaluates, and validates file conformance to GS1 EPCIS DSCSA requirements for structure, content, and schema. It is used by pharmaceutical manufacturers, repackagers, and wholesalers to demonstrate that their EPCIS files meet regulatory requirements before exchanging data with trading partners.
- VRS Verify An independent, unbiased VRS (Verification Router Service) Conformance Testing Platform that tests Level 1 and Level 2 VRS scenarios to ensure systems respond correctly to product verification requests. Used by pharmaceutical manufacturers and solution providers to verify product verification readiness before going live.
- GS1 Certified Testing Service The certified service through which Gateway Checker, as the only GS1 US-accredited Conformance Testing Service, provides objective, independent conformance testing for pharmaceutical supply chain partners. Certified for EPCIS and VRS product verification testing, it issues GS1 US Trustmarks to companies that pass conformance scenarios.
- Gateway Certified Program An industry seal-of-approval accreditation program demonstrating commitment to FDA DSCSA compliance standards. Leveraging TraceReady, outbound files are tested under 16 different Pharmaceutical Traceability Scenarios; organizations that pass receive the Gateway Certified seal and may apply for GS1 US Trustmarks for each role-based scenario successfully executed.
- medTracker The underlying platform component that handles EPCIS file processing, checks representative serial numbers against existing databases, places duplicate files on hold automatically, and manages database storage for the Gateway Checker SaaS ecosystem.
Quantifiable outcome
- Over 80% of product verification requests successfully processed with 95% verified as 'True'
- +2 more outcomes
Companies that use Gateway Checker
Customer profileNamed customers6 records
Segments5 records
Ideal customer profiles5 records
Gateway Checker technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration6 records
Feature6 records
Gateway Checker partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core and minor.
- Movilitas.CloudcoreMovilitas.Cloud earned Gateway Certified accreditation becoming the first solution provider to earn recognition for both EPCIS and VRS. The partnership enables Movilitas.Cloud customers to meet DSCSA requirements with Gateway Checker conformance testing.
- Körber Supply ChaincoreKörber Supply Chain achieved Gateway Certified accreditation for STEPLogic Trace 9.1 EPCIS solution. Körber's supply chain software integrates with Gateway Checker for GS1 standards certification.
- BrandSure, LLCcoreGateway Checker Corporation is a wholly owned subsidiary of BrandSure, LLC. BrandSure owns and operates Gateway Checker as its primary business unit focused on pharmaceutical traceability and DSCSA compliance solutions.
- GS1 UScoreGateway Checker is certified by GS1 US as a Conformance Testing Service. The company is the only organization with this accreditation and issues GS1 US Trustmarks to companies that pass conformance testing scenarios.
- Blue Link AssociatescoreBlue Link ERP integration with Gateway Checker enables pharmaceutical customers to meet DSCSA requirements. Blue Link's ERP system connects to Gateway Checker QA system for test file generation and provides customers with affordable DSCSA compliance functionality.
- Healthcare Distribution Alliance (HDA)minorGateway Checker participates in HDA VRS Quarterly Updates and traceability work groups. The HDA developed the Verification Router Service (VRS) standard that Gateway Checker tests and certifies.
- AS2 Solution ProviderscorePre-established AS2 connections with major solution providers including TraceLink, LSPedia, rfxcel, and Infinitrak. These connections enable secure EPCIS file transmission between trading partners through Gateway Checker's AS2 platform.
Scale indicators5 records
Recent moves6 records
Expansion highlights4 records
Gateway Checker competitors and assessment
Company assessmentDirect peers
- Movilitas.Cloud: Movilitas.Cloud is a SaaS supply chain traceability and serialization platform — and also a Gateway Checker customer, being the first solution provider to earn Gateway Certified accreditation for both EPCIS and VRS.
- TraceLink: TraceLink is the largest pharmaceutical serialization and supply chain platform, integrating with Gateway Checker via pre-established AS2 connections and serving many of the same drug manufacturers, wholesalers, and dispensers under DSCSA.
- rfxcel: rfxcel is a pharmaceutical serialization and traceability solution provider that is both a Gateway Checker integration partner and a direct competitor in EPCIS/VRS conformance and supply-chain visibility tooling.
- LSPedia: LSPedia provides serialization and DSCSA compliance software for pharma manufacturers and 3PLs, and is integrated with Gateway Checker's AS2 network — competing head-on for EPCIS file validation and product verification workloads.
- Systech: Systech offers serialization, traceability, and brand protection solutions for pharmaceutical and consumer goods supply chains, making it a direct peer in EPCIS conformance testing and DSCSA readiness services.
- Körber Supply Chain: Körber's STEPLogic Trace software is a pharma serialization and traceability platform integrated with Gateway Checker for EPCIS conformance certification, making it a direct channel partner and adjacent competitor.
Broad incumbents
- OPTEL Group: OPTEL is a larger, established pharma track-and-trace vendor offering serialization, traceability, and compliance solutions across the drug supply chain — an incumbent peer with overlapping DSCSA capabilities.
- Antares Vision: Antares Vision is a global track-and-trace and inspection technology provider for pharma and life sciences, offering broader serialization platforms that overlap with Gateway Checker's DSCSA conformance scope.
Others
- Blue Link Associates: Blue Link is a pharmaceutical-focused ERP vendor that embeds Gateway Checker's QA system for EPCIS file generation — an integration partner and adjacent ecosystem enabler rather than a direct competitor.
- Advasur: Advasur provides AS2 connectivity and EDI gateway services for pharma trading partners, with Gateway Checker pre-integrated to its AS2 endpoint — an infrastructure enabler in the same DSCSA ecosystem.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights6 records
Customer concentration
Gateway Checker social profiles
Digital presenceGateway Checker compliance and trust
Trust signalCompliance2 records
Gateway Checker financial estimates
Financial estimateRevenue estimate
Valuation estimate
Gateway Checker leadership team
Management profileNumber of profiles
Profiles1 record
Gateway Checker funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Gateway Checker M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Gateway Checker
What does Gateway Checker do?
Gateway Checker provides SaaS applications and programmable interfaces for testing, validating, and certifying EPCIS file conformance and VRS product verification readiness in pharmaceutical supply chains under FDA DSCSA requirements. Its TraceReady platform performs automated conformance testing across 16 Pharmaceutical Traceability Scenarios, complemented by EPCIS Verify, VRS Verify, and the Gateway Certified accreditation program that issues GS1 US Trustmarks to certified trading partners.
Is Gateway Checker a public or private company?
Gateway Checker is a private company. It is classified as corporate owned and is currently operating.
When was Gateway Checker founded?
Gateway Checker was founded in 2019. It employs 11 to 50 people.
Where is Gateway Checker based?
Gateway Checker is headquartered in Lexington, United States, in the North America region.
How does Gateway Checker make money?
Three revenue lines are on record. SaaS Subscription Services are the primary driver. The others are conformance Testing Services and professional Services.
Who are Gateway Checker's main competitors?
Direct peers on record are Movilitas.Cloud, TraceLink, rfxcel, LSPedia, Systech and Körber Supply Chain. Broad incumbents are OPTEL Group and Antares Vision. Others are Blue Link Associates and Advasur.
Does Gateway Checker have an API?
No public API is recorded for Gateway Checker.
What industry is Gateway Checker in?
Gateway Checker's product category is Pharmaceutical Supply Chain Compliance Software. Its primary akta.pro industry code is AFALAGAK, Third-Party Traceability Platform Assurance (SOC/ISO-aligned controls for traceability data). Its NAICS code is 54138 and its SIC code is 8734.