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  • Home
    • About Us
    • Careers
  • Services
    • Compliance Focused
      • Misalignment Exceptions Management (US DSCSA)
      • EU Alert Management
      • Middle East Serialization Consulting
      • China Reporting Services
    • Business Operations Focused
      • Master Data Management
      • Trade Partner Onboarding
      • Level 4 System Validation
      • Serialization System Health Check
    • Business Processes Outsourcing
      • Managed Services CoE
      • US DSCSA Ti Digitization
  • Our Solutions
    • Traceware
    • nTrack
  • Clients
  • Blog
    • Serialization
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Strengthening Global Health Supply Chains: USAID’s Approach to Enabling Traceability in Africa

Strengthening Global Health Supply Chains: USAID’s Approach to Enabling Traceability in Africa

Mar 14, 2025 |

Ensuring the authenticity and safety of medical products is a critical priority in global health supply chains. The U.S. Agency for International...
Navigating Misalignment Exception Management Under DSCSA: Challenges and Solutions

Navigating Misalignment Exception Management Under DSCSA: Challenges and Solutions

Feb 28, 2025 |

The U.S. Drug Supply Chain Security Act (DSCSA) aims to enhance pharmaceutical traceability, but misalignment exceptions remain a persistent challenge....
Italy's Transition from Bollino to EU-FMD: Proposed Deadline Extension and Industry Implications

Italy's Transition from Bollino to EU-FMD: Proposed Deadline Extension and Industry Implications

Feb 7, 2025 | Serialization, Regulations

Reference: 19th Legislature - 10th Permanent Commission - Summary report no. 247 of 26/11/2024 (Accessed on February 6, 2025....
Italy’s Transition from Bollino to FMD: Challenges and Preparation Guide for Pharmaceutical Manufacturers

Italy’s Transition from Bollino to FMD: Challenges and Preparation Guide for Pharmaceutical Manufacturers

Jan 24, 2025 | Serialization, Regulations

Italy is embarking on a significant shift in its pharmaceutical regulation by transitioning from the Bollino system to the European Union’s Falsified...
Pharmaceutical Serialization in the GCC: Progress, Challenges, and Future Directions

Pharmaceutical Serialization in the GCC: Progress, Challenges, and Future Directions

Jan 17, 2025 | Serialization

Pharmaceutical serialization, a cornerstone of supply chain security, is rapidly advancing across the Gulf Cooperation Council (GCC) countries. This...
Overview of Indonesia’s Pharmaceutical Serialization Regulations

Overview of Indonesia’s Pharmaceutical Serialization Regulations

Jan 3, 2025 | Serialization, Pharmaceutical, Regulations, Compliance

The Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) or Badan POM, also known as the Indonesian FDA, is a government agency in...
US Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions - WEE’s

US Drug Supply Chain Security Act (DSCSA) Waivers, Exceptions, and Exemptions - WEE’s

Dec 20, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

The US DSCSA, enacted in 2013, aims to create a system for tracking prescription drugs as they are distributed within the United States. The act is...
The Importance of Master Data Management in Pharmaceutical Track & Trace

The Importance of Master Data Management in Pharmaceutical Track & Trace

Dec 13, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Serialization involves assigning serial numbers to products or packaging units, requiring a defined set of attributes for tracking and tracing. Master...
CSV in Pharmaceuticals: Challenges and Solutions

CSV in Pharmaceuticals: Challenges and Solutions

Dec 6, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Pharmaceutical manufacturers face several challenges specific to Computer System Validation (CSV) due to the industry's stringent regulatory and...
UAE TATMEEN - Pharmaceutical Drug Traceability

UAE TATMEEN - Pharmaceutical Drug Traceability

Nov 22, 2024 | Serialization, Pharmaceutical, Regulations, Compliance, Aggregation

The UAE Ministry of Health and Prevention issued Legislative Decree No. (73) of 2021 on June 14, 2021, regarding Pharmaceutical Products Traceability....
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    Recent Posts

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