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
-
[Checklist] Serialization Readiness Checklist 2026 (L1–L5)
in news, WhitepapersSerialization Readiness Checklist 2026 (L1–L5) Are you actually ready for serialization changes in 2026? Most pharma companies say they are. Very few have actually checked. Regulatory updates, new markets, system upgrades, partner cha...
-
[Blog] Traceability of Medicines in Indonesia: Regulatory Requirements, Timelines, and Compliance Strategy
Traceability of Medicines in Indonesia: Regulatory Requirements and Compliance Indonesia represents one of the most dynamic pharmaceutical markets in Southeast Asia. With a population of nearly 280 million and expanding access to healthcare, t...
-
[Press Release] SoftGroup Announces Partnership with DS Pharma Services Pte Ltd in Singapore and Southeast Asia
in news, Press ReleasesSofia, Bulgaria – January 2026 – SoftGroup, a provider of end-to-end serialization, aggregation, and track & trace solutions for the pharmaceutical industry, today announced a strategic partnership with DS Pharma Services Pte Lt...
