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 21+ 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.
SOLUTIONS
Serialization and Compliance from Level 1 to Level 5 – Hardware, Software, Data Exchange and Regulatory Connectivity
Global Regulatory Compliance Software | Level 5
SATT PLATFORM provides automatic and secure communication with national regulatory systems – ensuring reliable reporting for pharmaceutical serialization and traceability.
The solution supports real-time data exchange with multiple authorities, including EMVO, Tatmeen, ASL Belgisi, IS MPT, ЦДМ, EBD, DVTIS, NHRA-MVC. All connections follow the latest compliance requirements and are maintained to reflect evolving regulatory changes.
Designed for:
Manufacturers, MAHs, CMOs, Wholesalers, Repackagers and 3PLs operating in regulated markets.
External Network Communication | Level 4
Designed for:
Pharma companies managing cross-platform operations and supply chain collaboration.
Enterprise Management | Level 3
Designed for:
Pharmaceutical manufacturers and MAHs managing multiple lines, CMOs, or partners across regions looking to scale operations without losing control.
Line Management | Level 2
Serialization and Aggregation Hardware | Level 1
Designed for:
Pharmaceutical manufacturers and packaging sites that require validated, ready-to-use serialization hardware aligned with regulatory and operational demands.
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.
SoftGroup delivered a user-friendly, technology-driven platform built on collaboration and trust. As a small company, having partner that understands our needs and provides the right tools is invaluable. SoftGroup's experitse makes them a truly reliable serialization partner.
SoftGroup is more than vendor - they're a partner. In the pharma industry, companies need scalable, dependable solutions. SoftGroup is always there to support our growth and adapt to our evolving needs.
SoftGroup is characterized by a high level of services, reliability and business integrity. We recommend SoftGroup as a competent, responsible and professional partner for serialization and aggregation.
WHY SOFTGROUP?
Pharma Software that Adapts to You
Whether you're outsourcing production or managing multiple lines, our software adapts to your setup. Fast to implement, easy to scale and designed to simplify compliance from day one.
In-House Tech. Built for Pharma.
From software to hardware, everything we deliver is developed by SoftGroup. That means faster support, easier integration and full regulatory control.
Works With Your Systems. Backed by Experts.
We make integration simple - no disruption, no hidden costs. Whether you're starting fresh or upgrading, our team ensures smooth implementation and full cycle support.
NEWS
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[Blog] New Traceability Rules in Ethiopia: What Pharma Exporters Must Do by 2026
New Traceability Rules in Ethiopia: What Pharma Exporters Must Do by 2026 The Ethiopian Food and Drug Authority (EFDA) is taking a major step forward in securing its pharmaceutical supply chain. With the launch of the EFDA-MVC Traceability Hub...
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[Blog] Inside Italy’s FMD Roadmap: What MAHs Need to Do Before October 2025
Italy’s FMD Timeline at a Glance Italy’s transition to full EU Hub integration is well structured and full of deadlines. Here’s the timeline all MAHs should track: Until Feb 2027: Stabilization period; use of the “bollino” still allo...
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[Blog] Greece’s Real Serialization Progress: 10,881 Users Onboarded. But What’s Next for MAHs?
Snapshot: Greece’s Onboarding Progress Greece has made notable strides in FMD implementation. As of Q2 2025, the Hellenic Medicines Verification System (HMVS) has: 10,507 private pharmacies 135 public hospitals 148 wholesalers 91 private hos...
