ABOUT US
Serialization & Aggregation Solutions for Global Compliance
SoftGroup empowers pharmaceutical and MedTech companies with end-to-end track & trace solutions that ensure compliance and drive operational efficiency.
With 20+ years of expertise, we are a trusted serialization and traceability partner of Big Pharmaceutical Leaders with complex production, as well as Marketing Authorization Holders (MAHs) with no in-house manufacturing.
Have a traceability challenge? Let’s talk.
WHY SOFTGROUP?
Serialization & Aggregation Hardware Solutions
Ensure full compliance and product integrity with serialization, aggregation, and tamper-evidence hardware. Designed to meet global and local regulatory requirements, these solutions enable seamless track & trace integration from the production floor to distribution.
Traceability & Machine-Level Management
SoftGroup® SaTT Line Controller enables real-time batch processing, automated printing control and verification, ensuring precision and compliance in serialization and aggregation.
Enterprise Serialization & Compliance Management
SATT PLATFORM EBR centralizes serialization, ensuring compliance and traceability and full auditability across multiple production lines. The system provides seamless batch control, regulatory reporting and data integrity for global compliance.
External Network Communication & Partner Integration
SoftGroup® SaTT Communication Cloud enables real-time data exchange between supply chain partners, contract manufacturers and regulatory authorities. This ensures seamless compliance, partner collaboration and traceability across networks.
Regulatory Communication & Compliance
Seamless compliance with a global network of regulatory bodies. SoftGroup ensures real-time data exchange and automated reporting with authorities worldwide by simplifying compliance for pharmaceutical manufacturers and CMOs.
Vaccine Traceability Solution
SoftGroup® SaTT Gateway is the most user-friendly and fully automated SaaS software for meeting compliance for traceability and serialization.
Trusted by Pharma Leaders Worldwide
When you choose SoftGroup, you join leading pharmaceutical manufacturers, contract manufacturers, parallel importers, distributors, and wholesalers who rely on our serialization and traceability solutions for compliance and operational efficiency.
The flexibility of SoftGroup’s solution and its ability to connect to multiple systems is a real advantage for a small MAH like us. What makes SoftGroup stand out is their personal, hands-on support. We’ve felt like a priority from the beginning.
SoftGroup made our EU Hub onboarding clear, simple, and fully compliant. We had confidence in their team from day one. The knew the EMVS requirements inside out. Their continued support gives us peace of mind in our day-to-day serialization activities.
With SoftGroup's platform, we ensure full transparency and product integrity across our supply chain. The platform provides complete serialization management, regulatory reporting, secure data exchange and full EU FMD compliance.
SOLUTIONS
Serialization & Compliance Solutions for Every Pharma Business.
All in One Platform.
End-to-end serialization, aggregation, and compliance solutions – scalable for pharmaceutical companies of all sizes.
Serialization & Aggregation Hardware Solutions
Traceability & Machine-Level Management
Enterprise Serialization & Compliance Management
External Network Communication & Partner Integration
Regulatory Communication & Compliance
Vaccine Traceability Solution
NEWS
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[Blog] Serialization Now Mandatory in Algeria: What the New 2025 Decree Means for Pharma Importers
A Major Compliance Shift: Algeria Makes Serialization Mandatory On October 12, 2025, Algeria’s Ministry of Pharmaceutical Industry introduced a decisive regulatory step forward. The Ministerial Decree No. 25 (Arrêté N°25 du 12 Octobre 202...
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[Blog] Traceability of Medicines in Guinea-Bissau: Key Regulatory Deadlines and Requirements
Guinea-Bissau: Key Regulatory Deadlines and Requirements On 19 September 2025, the Government of Guinea-Bissau officially established its national pharmaceutical traceability system – the AVG Pharmaceutical Traceability Hub. The initiative w...
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[Blog] Cybersecurity Risks in Pharma: Why Identity and Cloud Security Are Now Compliance Priorities
Cybersecurity Risks in Pharma: Why Identity and Cloud Security Are Now Compliance Priorities Cyberattacks against manufacturing companies are growing in scale and precision. According to the IBM X-Force Threat Intelligence Index 2025, manufact...
