FDA introduces a standardized 12-digit NDC format Pharmaceutical companies are preparing for multiple regulatory milestones under the U.S. Drug Supply Chain Security Act (DSCSA). Alongside these requirements, the U.S. Food and Drug Administration (FDA) has introduced another structural change that will affect how medicines are identified,...
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SoftGroup Receives EcoVadis Committed Badge (February 2026) SoftGroup has been assessed by EcoVadis and awarded the Committed Badge (February 2026). This recognition reflects our structured approach to sustainability and responsible business practices across key areas relevant to global supply chains. About the EcoVadis Assessment EcoVadis is one of...
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Serialization 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 changes - none of these test a single tool. They test the entire L1–L5 serialization setup. This...
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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, the market was valued at approximately USD 7–8 billion in 2020 and is...
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Sofia, 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 Ltd, a Singapore-based company specializing in pharmaceutical serialization systems, packaging solutions, and validation services. Through this collaboration,...
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Traceability of Medicines in Egypt: A Practical Guide to Serialization and Track & Trace Compliance In recent months, several pharmaceutical companies preparing exports to Egypt raised the same concern during readiness discussions: “We already serialize - are we actually compliant for Egypt?” In one case, a shipment...
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One Year of TRVST Connectivity: What Operational Readiness Really Means Counterfeit and falsified medicines are not a theoretical risk. According to UNICEF and the World Health Organization, counterfeit and falsified medicines are estimated to cause the death of 169,000 children under the age of five every year,...
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Pharma Traceability Deadlines for 2026–2027: Your Complete Regulatory Roadmap Why 2026–2027 can’t be “just another year” 2026 will be one of the most demanding years for pharmaceutical traceability. New serialization, aggregation and reporting rules go live across multiple markets – within months, not years. Armenia, Egypt, Ethiopia, Guinea-Bissau, Rwanda...
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Why Identity Security Matters in Pharma: Phishing, Privileges and Passwords in 2025 Digital identity is now the primary entry point for cyberattacks in the pharmaceutical industry. With production systems, serialization environments, and partner networks becoming increasingly interconnected, a single compromised account can disrupt entire operations and...
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Maximizing Production Efficiency with "True Flexibility" The Challenge: The Conflict Between Rigid Plans and Dynamic Reality Pharmaceutical production is a highly regulated, complex process that often relies on production plans prepared months in advance. However, real-world manufacturing environments are rarely static. Market demands shift, machine availability changes,...
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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 2025), published in the Official Journal of the Algerian Republic, now makes serialization...
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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 was launched under Dispatch No. 31/GMSP/2025 and the Joint Dispatch of the General Health Inspection Office (IGAS) and...
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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, manufacturing remains the most targeted industry worldwide for the fourth year in a row. Attackers...
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The future of pharma compliance is already here. Are you ready to scale it? At CPHI Frankfurt, 62,000+ pharmaceutical professionals will explore what’s next in manufacturing, technology, and global supply chain transformation. It’s the perfect place to meet the team behind one of the most flexible,...
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New SAHPRA Traceability Guideline Outlines Step-by-Step Implementation Roadmap The South African Health Products Regulatory Authority (SAHPRA) has published its official Traceability Guideline, defining a structured roadmap for introducing unique product identification and unit-level serialisation across all health products in South Africa. This marks a significant shift from...
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Africa’s Road to Pharma Traceability: Updates from 2025 Onwards Counterfeit medicines remain one of the biggest health threats in Africa. The World Health Organization (WHO) estimates that the continent accounts for 42% of all falsified medicines worldwide, and in some low- and middle-income countries, 10% of...
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SoftGroup Joins GS1 Algeria Healthcare Traceability Day Together with our local partner IDVEY, SoftGroup participated in the GS1 Algeria Healthcare Traceability Day to discuss the future of serialization and regulatory readiness in the Algerian market. Event Highlights Regulatory Alignment: Algeria is expected to move toward serialization and...
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SoftGroup Brings Next-Gen Track & Trace Insights to Uzbekistan SoftGroup participated in the 4th International Congress & Exhibition Pharma Uzbekistan & Central Asia in Tashkent on September 24–25, 2025, presenting expert insights on serialization, aggregation, and compliance readiness across the CIS region. Sessions Led by SoftGroup Next-Gen Track...
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SoftGroup at Pharma Anti-Counterfeiting & Serialization 2025 in Washington, D.C. SoftGroup was proud to be a Silver Sponsor of the 16th Annual Pharma Anti-Counterfeiting, Serialization & Supply Chain Security Conference, held on September 18, 2025, in Washington, D.C. SoftGroup’s Contribution Our Director of Business Development and Sales, Dr....
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Ukraine’s Potential Path to a National Medicines Verification System by 2028 Ukraine has taken a decisive step toward aligning its pharmaceutical supply chain with European Union standards. On 26 September 2024, the Cabinet of Ministers of Ukraine approved the creation of a national medicines verification system...
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