DSCSA Enforcement Begins: A Global Signal for Supply Chain Transparency Published: June 2025 | Author: SoftGroup Editorial Team As of May 27, 2025, the U.S. Food and Drug Administration (FDA) has officially begun enforcing the Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers and repackagers. This...
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Pharmaceutical Cybersecurity at Risk: Lessons from Void Blizzard As the pharmaceutical industry continues to embrace digital transformation, the security of sensitive data and systems becomes not just an IT issue, but a compliance and operational priority. A new cyber threat, uncovered by Microsoft and known as...
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Why Serialization Compliance Is Critical for New CMOs Starting your journey as a Contract Manufacturing Organization (CMO) in the pharmaceutical industry requires more than production capabilities. Whether you’re operating in the European Union only or expanding into international markets like the United Arab Emirates, your ability...
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SATT PLATFORM: Compliance and Serialization Software for Pharma In today’s pharmaceutical industry, compliance is non-negotiable, but that doesn’t mean it should slow you down. Managing serialized production, responding to evolving regulations, and scaling across global operations requires a platform that understands both the regulatory and operational...
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Pharmaceutical Serialization in Pakistan: What You Need to Know Ahead of the 2025 Deadline As the pharmaceutical industry in Pakistan prepares for the full implementation of serialization regulations, August 2025 marks a significant compliance milestone. The Drug Regulatory Authority of Pakistan (DRAP) has set a clear...
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ResolverRAT: What Pharma Leaders Need to Know About This Advanced Threat A new malware threat is quietly targeting healthcare and pharmaceutical companies — and it’s engineered to bypass traditional security measures entirely. ResolverRAT, first identified in March 2025, uses advanced in-memory execution, regionalized phishing emails, and encryption...
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SATT PLATFORM®: The Future of Compliance and Efficiency in Pharmaceutical Manufacturing Pharmaceutical production is a delicate balance between efficiency, regulatory compliance, and operational flexibility. Traditional systems often impose rigid structures, limiting manufacturers' ability to adapt to market shifts, production demands, or last-minute regulatory requirements. This is where...
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Mandatory Digital Labelling of Medical Devices in Uzbekistan: What You Need to Know Uzbekistan's pharmaceutical and medical device industries are undergoing significant regulatory changes with the introduction of mandatory digital labelling. Starting February 1, 2025, medical devices will require digital serialization to enhance traceability, combat counterfeiting,...
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Italy’s Serialization Update: Key Requirements and What It Means for Pharma Companies Italy has significantly strengthened pharmaceutical compliance with the first implementing decree under the Falsified Medicines Directive (FMD). The decree mandates using a 2D Data Matrix barcode on secondary packaging, aligning with EU serialization standards. This...
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Beyond Barcodes: How Serialization Powers Compliance & Supply Chain Security Serialization in pharmaceuticals is often reduced to a simple concept - applying barcodes to product packaging. But in reality, it is a sophisticated framework that ensures regulatory compliance, secures global supply chains, and provides pharmaceutical companies...
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Serialization Compliance Mistakes That Can Cost Millions Pharma companies that fail to comply with serialization regulations risk millions in fines, product recalls, and reputational damage. Yet, despite its importance, many companies still make avoidable mistakes that put their operations at risk. In this article, we’ll explore the...
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Armenia Delays Mandatory Serialization for Medicines with Crypto Codes Until 2026 - What This Means for Pharma Companies The pharmaceutical industry in Armenia has been granted additional time to comply with mandatory serialization requirements. According to Government Decision No. 125-N, issued on February 6, 2025, the...
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Bahrain’s NHRA-MVC System Upgrade: What It Means for Pharmaceutical Compliance Bahrain's National Health Regulatory Authority (NHRA) has officially launched its upgraded NHRA-MVC system, marking a crucial step in ensuring compliance with Legislative Decree No. 41 (2017) for pharmaceutical track-and-trace. This upgrade strengthens Bahrain’s commitment to secure,...
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How Azure-Based Solutions Strengthen Data Security for Pharma Operations | Compliance & Protection The pharmaceutical industry is one of the most regulated industries worldwide, and the companies within it are one of the most observed. Why? Talking about patient safety puts data security as the focus....
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Italy's Serialization Update 2025: Key Compliance Changes for Pharma Companies On 28 January 2025, the Italian Council of Ministers approved a new legislative decree aligning Italy with the EU Falsified Medicines Directive (FMD). This long-awaited update introduces a two-year stabilization period, giving pharmaceutical manufacturers time to...
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Jordan FDA Extends Serialization Compliance Deadline to June 2025 The Jordan Food and Drug Administration (JFDA) has announced an extension of the compliance deadline for implementing DataMatrix codes and serialization on secondary packaging of regulated pharmaceutical products. The new deadline is set for June 30, 2025. Serialization...
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Replacing Outdated Serialization Systems: A Practical Guide for Compliance and Efficiency In the pharmaceutical industry, serialization is the backbone of compliance and operational efficiency. However, many companies still rely on outdated systems that create unnecessary challenges. Whether it’s meeting new regulations, managing complex supply chains, or...
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The Role of Data Integrity in Pharma: Why It’s Critical for Pharma Compliance Data integrity is a cornerstone of compliance in the pharmaceutical industry, where patient safety and product quality are paramount. With stringent regulatory requirements and the increasing complexity of global supply chains, maintaining accurate,...
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Scaling Compliance and Operations with the SATT PLATFORM A Free Webinar for Pharma Professionals to Master Compliance and Operational Excellence. Discover how the SATT PLATFORM enables pharmaceutical companies to scale globally while ensuring regulatory compliance and operational efficiency Compliance and operational efficiency are among the most critical challenges...
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Trends for Mission-Critical Workloads in 2025: Future-Proofing Pharma Operations In the pharmaceutical industry, mission-critical workloads are the lifeblood of operations, ensuring compliance, security, and efficiency. As we move to the 2025, technologies like SATT PLATFORM are at the forefront of enabling seamless and reliable workloads for...
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