Global Regulatory Connectivity | Level 5

Financial Planing

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OUR PHILOSOPHY

Secure and Compliant Connectivity to National Regulatory Systems

The SATT PLATFORM level 5 solution enables secure, automated communication with national regulatory systems, ensuring reliable reporting for pharmaceutical serialization and traceability. The platform supports real-time data exchange with multiple authorities. All integrations are continuously maintained to reflect evolving regulatory and compliance requirements.

Designed for:

Manufacturers, MAHs, CMOs, Wholesalers, Repackagers, and 3PLs operating in regulated markets.

Each integration is delivered as a dedicated national gateway within the SATT PLATFORM Level 5.

The SATT PLATFORM EU Hub Gateway enables secure and compliant reporting to the European Medicines Verification System (EMVS).

The solution supports the submission and update of Product Master Data (PMD) and Product Pack Data (PPD) to the EU Hub, with full control over which serialized batches are reported. It ensures reliable status verification for all serial numbers, covering all EMVO-defined states, including active, decommissioned, recalled, stolen, and destroyed, etc.

Incoming alerts and notifications from EMVS are automatically processed, with confirmation messages returned to the source system after successful transmission to national systems.

Key outcome:

Reliable EU FMD reporting with full status control and alert visibility.

The SATT PLATFORM Uzbek Hub Gateway enables compliant data exchange with ASL Belgisi, the Uzbekistan National Track & Trace System.

The solution supports cryptographic protection for serialized products, including the generation and management of crypto keys and signatures for each serial number. It allows publishing the serialization and aggregation reports with unlimited data volume. SATT PLATFORM Uzbek Hub Gateway allows our customers to obtain a complete set of statuses and functionalities required by Asl Belgisi, ensuring that all customer requirements and operations are supported to maintain continuity and smoothness.

All required statuses and regulatory events are supported, with automated notifications exchanged with the national system.

Key outcome:

Secure, crypto-enabled reporting aligned with Uzbekistan track & trace regulations.

The SATT PLATFORM UAE Hub Gateway provides secure connectivity to the UAE Tatmeen digital platform, enabling compliant serialization and aggregation reporting across all supply chain actors.

The solution supports access to Product Master Data (PMD) and the submission of Product Pack Data (PPD), including serial and aggregation reports for all packaging levels. The system supports Authority Permit data, all reporting events, and functionalities, required by the UAE Ministry of Health and Prevention (“MOHAP”).

 

Key outcome:

End-to-end Tatmeen compliance with real-time reporting and verification.

The SATT PLATFORM Kazakh Hub Gateway enables compliant data exchange with IS MPT, the Kazakh National Track & Trace System.

The solution supports cryptographic protection for serialized products, including the generation and management of crypto keys and signatures for each serial number. It allows publishing the serialization and aggregation reports with unlimited data volume. SATT PLATFORM Kazakh Hub Gateway allows our customers to obtain a complete set of statuses and functionalities required by IS MPT, ensuring that all customer requirements and operations are supported for continuity and smoothness.

All required statuses and regulatory events are supported, with automated notifications exchanged with the national system.

Key outcome:

Secure, crypto-enabled reporting aligned with Kazakh track & trace regulations.

The SATT PLATFORM Kyrgyz Hub Gateway enables secure communication with ИС ЭБД (IS EBD), the Kyrgyz National Track & Trace System for pharmaceuticals and medical devices and all participants across the supply chain, including MAHs, Manufacturers, Importers, Wholesalers, etc.

The solution supports final batch data upload and reporting of serialization and aggregation events in accordance with national resolutions and Ministry of Health requirements. It allows our customers to obtain a complete set of statuses and functionalities as required by IS EBD, ensuring that all customer requirements and operations will be supported to ensure continuity and smoothness.

Key outcome:

Reliable compliance with Kyrgyz traceability requirements through automated reporting.

The SATT PLATFORM AZ Hub Gateway is a regulatory-compliant software solution designed to establish a direct connection for data exchange between foreign Manufacturers/Marketing Authorization Holders (MAHs) and their authorized local importers or distributors in the Republic of Azerbaijan.

The platform facilitates the transmission of final batch information reports in the required standardized formats (EPCIS, XML, etc.) for subsequent reporting submission to the Azerbaijan National Track & Trace System for Medicines (DVTIS).

Key outcome:

Consistent serialization reporting aligned with Azerbaijan regulatory requirements.

The SATT PLATFORM Bahrain Hub Gateway provides a seamless connection and data exchange between the Bahrain National Track & Trace System (NHRA-MVC) and all relevant stakeholders.

It enables the uploading of required Product Master Data (PMD) for imported or locally manufactured medicines and supports the publishing of Product Pack Data (PPD), including serial numbers, aggregation data, and reports across all packaging levels. 

Key outcome:

Controlled and auditable traceability reporting for Bahrain market.

The SATT PLATFORM Armenian Hub Gateway establishes an automatic connection and facilitates seamless data exchange between the Armenian National Track & Trace System – AIS MT and all participants across the supply chain, including MAHs, Manufacturers, Importers, Wholesalers, etc.

This solution empowers users to effortlessly request and receive cryptographic protection, encompassing crypto keys and signatures for each serial number. Furthermore, it supports the publishing of serialization and aggregation reports, if aggregation is required, with unlimited data volume.

Key outcome:

Secure, crypto-enabled reporting aligned with Armenian track & trace regulations.

SATT PLATFORM KZ EDO facilitates communication and data exchange between the Kazakhstan ЦЭДМ system and participants in the supply chain (importers, distributors, wholesalers, and registration certificate holders).

The system is designed to ensure traceability of marked goods through document generation. 

SATT PLATFORM provides a secure, cloud-based connection to the TRVST vaccine traceability system, enabling compliant reporting and regulated data exchange in accordance with the applicable TRVST framework and technical specifications.

The solution supports automated submission of batch and serialization data, acknowledgements, and audit-ready traceability records, ensuring reliable communication between vaccine manufacturers, supply chain participants, and the traceability system.

Designed for:

Vaccine manufacturers, MAHs, and supply chain partners operating within regulated vaccine traceability programs.

REGULATORY REPORTING | LEVEL 5

Direct Reporting to National Regulatory Systems

Through the SATT PLATFORM Level 5 services, your serialization system connects directly to national regulatory authorities via secured hub gateways.

The platform ensures compliant submission of product and pack data, real-time status updates, and reliable regulatory communication across EU and non-EU markets, aligned with local rules and reporting timelines.

How SATT PLATFORM’s Level 5 Works

From Serialization Data to Regulatory Reporting

01

Regulatory Data Preparation

Serialization, aggregation, and master data are validated and structured according to each national authority’s reporting requirements.

02

Secure National Hub Connection

SATT PLATFORM connects your system to national regulatory hubs through validated, country-specific gateways.

03

Regulatory Data Submission

Product, pack, and event data is reported in the required formats, message structures, and timelines defined by local regulations.

04

Acknowledgement, Alerts & Audit Readiness

Confirmations, alerts, and status updates are received, logged, and monitored to ensure full traceability and audit compliance.

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