country COMPLIANCE REPORTING 

Automate Global Regulatory Reporting with Audit-Ready Data 

AltiusHub simplifies compliance reporting across international markets by automating data exchange, adapting to evolving regulations, and ensuring complete data integrity. 

BUSINESS CHALLENGES 

Too Many Formats. Not Enough Flexibility 

Compliance today goes beyond just submitting reports. It demands constant adaptation to evolving country regulations, diverse EPCIS formats, and changing partner requirements.  

Without a flexible, event-driven architecture, compliance teams are left patching together fragmented systems, and revalidating files; all at the expense of time, accuracy, and operational confidence. 
HIGH-VOLUME, LOW VISIBILITY
INEFFICIENT, STATIC SYSTEMS 
ONBOARDING BOTTLENECKS 
High-Volume, Low Visibility

Too much data with very little control 

  • Lack of unified view prevents oversight into submissions and file processing status. 
  • Manual data entries result in outdated or inconsistent compliance records. 
  • Compliance teams get overwhelmed while manually validating thousands of serialized events.
INEFFICIENT, STATIC SYSTEMS

Changing regulations require advance infrastructure

  • Rigid architectures demand long development cycles for every compliance update, delaying go-to-market.
  • Investigating suspect or illegitimate products is time-consuming without audit-ready, event-level histories.
  • Inconsistencies in enforcement of business rules across markets lead to frequent reporting errors.
ONBOARDING BOTTLENECKS

More partners mean more complexity

  • Legacy systems require custom builds for every new partner addition, draining IT bandwidth and increasing integration costs.
  • Lack of scalable onboarding slows time-to-compliance and weakens partner trust.
  • Disconnected partner systems result in duplicate, missed or delayed event data.
OUR SOLUTIONS 

Built to Scale with
Evolving Global Regulations 

FUTURE-READY COMPLIANCE FOUNDATION 

Scale effortlessly across geographies  

  • SaaS-based, scalable architecture with automated updates; no manual IT effort needed. 
  • Robust reporting engine that adapts to diverse, evolving regulatory guidelines. 
  • No-code configuration of market-specific rules and reporting requirements. 
COMPREHENSIVE EVENT-BASED REPORTING 

Generate accurate reports exactly when needed 

  • Automated capture of critical events throughout the product lifecycle. 
  • Built-in intelligent error detection layer ensures 100% data accuracy. 
  • Optimized infrastructure for high-volume data exchange and real-time insights. 
ADVANCE ISSUE MANAGEMENT 

Stay ahead of risks with proactive monitoring 

  • Advanced real-time monitoring system for failed events, data mismatches, and missing records. 
  • Intuitive interface with insights into failure reasons, retry mechanisms, and complete audit trails.
  • Smart issue resolution engine with configurable rules to prioritize and solve critical issues. 
INDUSTRY RELEVANCE 

Navigate Pharma Compliance with Ease 

AltiusHub helps supply chain partners in the pharmaceutical industry manage serialization, track & trace, and compliance reporting aligned with country-specific regulations. 
nigeria
GS1 2D codes required for serialization. Reports sent to NAFDAC, following EPCIS and GS1 guidelines.
Kazakhstan
Serialized 2D codes with aggregation are required. Reporting is done to IS MPT using hybrid GS1 + local format.
saudi Arabia
Serialization and aggregation with SSCC barcodes are required. EPCIS-based reporting sent to SFDA’s RSD portal.
UAE
All drugs must carry GS1 2D barcodes. Serialized events (commissioning, shipping, returns) are reported to the Tatmeen portal.
Uzbekistan
Serialized and aggregated packaging is mandatory. Reports to CRPT Turon is EPCIS-based.  
India
Top 300 drug brands must display QR codes.  
All APIs must carry similar QR codes on labels, capturing batch number, expiry, and manufacturing details per CDSCO rules.
China
Data is reported to NMPA’s centralized platform using custom national format guidelines.
indonesia
GS1 2D barcode with serialized code is mandatory. Reporting to BPOM is done via standard EPCIS protocols.
russia
Crypto codes with a 2D Matrix are required. Reporting is done to Chestny ZNAK using secure crypto protocols.
EU
Product Packs must carry a 2D Data Matrix with a unique serial, GTIN, batch, and expiry. Reports are submitted to national systems via the EMVS.
Brazil
Serialized IUM (Unique Identifiers) is required on secondary packaging. XML-based reporting is submitted to the SNCM portal.
USA
Serialized product data (GTIN, Lot, Expiry, Serial No.) must be exchanged with partners using EPCIS. TI/TS/TH reporting is required for product tracing and saleable returns. 
Kazakhstan
Serialized 2D codes with aggregation are required. Reporting is done to IS MPT using hybrid GS1 + local format.
nigeria
GS1 2D codes required for serialization. Reports sent to NAFDAC, following EPCIS and GS1 guidelines.
saudi Arabia
Serialization and aggregation with SSCC barcodes are required. EPCIS-based reporting sent to SFDA’s RSD portal.
UAE
All drugs must carry GS1 2D barcodes. Serialized events (commissioning, shipping, returns) are reported to the Tatmeen portal.
India
Top 300 drug brands must display QR codes.  
All APIs must carry similar QR codes on labels, capturing batch number, expiry, and manufacturing details per CDSCO rules.
China
Data is reported to NMPA’s centralized platform using custom national format guidelines.
indonesia
GS1 2D barcode with serialized code is mandatory. Reporting to BPOM is done via standard EPCIS protocols.
russia
Crypto codes with a 2D Matrix are required. Reporting is done to Chestny ZNAK using secure crypto protocols.
EU
Product Packs must carry a 2D Data Matrix with a unique serial, GTIN, batch, and expiry. Reports are submitted to national systems via the EMVS.
Brazil
Serialized IUM (Unique Identifiers) is required on secondary packaging. XML-based reporting is submitted to the SNCM portal.
USA
Serialized product data (GTIN, Lot, Expiry, Serial No.) must be exchanged with partners using EPCIS. TI/TS/TH reporting is required for product tracing and saleable returns. 
EXPlore further

Learn More About Our Platform 

Serialization

Leverage smart serialization technology to authenticate products for seamless traceability. 

Track & Trace

Experience complete product visibility, from production to pharmacy with zero manual intervention. 

Reports & Analytics 

Turn complex supply chain data into actionable insights with dashboards and workflows. 
FAQS

Frequently asked questions

Got Questions? We’ve Got You Covered.
What is country compliance reporting in pharma?

Country compliance reporting is the process of generating and submitting the specific serialization and supply chain event data that each country's regulatory authority requires. Different markets mandate different data formats, reporting windows, submission protocols, and L5 system connections — all of which must be managed without separate infrastructure per country.

Which pharma traceability regulations does AltiusHub support?

AltiusHub supports EU FMD compliance, US DSCSA compliance, Russia MDLP compliance, Kazakhstan, Uzbekistan, UAE, Bahrain, Indonesia, and Saudi SFDA pharma traceability requirements. It is also building compliance modules for emerging markets like Egypt, South Africa, Nigeria, Zimbabwe, Algeria etc.

How does AltiusHub manage multi-country pharma compliance from one platform?

Each country's requirements are managed as a dedicated compliance module within AltiusHub due to modular architecture by covering specific data format, submission protocol (API, SFTP, web service), and reporting window. Adding a new market does not require a new system or custom development project. 

How does AltiusHub handle pharma regulatory updates without system revalidation?

Regulatory updates are applied at the platform level, not as customer-side revalidation projects. When a country changes its data format, reporting window, or submission protocol, AltiusHub updates the relevant compliance module. Manufacturers do not rebuild integrations, revalidate their systems, or engage implementation teams every time a regulation changes.

How does AltiusHub connect to L5 regulatory systems in pharma?

AltiusHub connects directly to each country's L5 regulatory system using the protocol that it requires such as REST APIs, SFTP file exchange, or web service submissions, depending on the market. These connections are pre-built, certified, and maintained within the platform. No custom middleware or third-party connector is required.

EXPERIENCE THE DIFFERENCE

Struggling with Compliance
Reporting Requirements?

With AltiusHub, managing and scaling your supply chain operations gets simpler. Schedule a demo to know more.
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Ready to Transform Your Supply Chain Operations? 

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