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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
    • Digital
  • News
  • Contact
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....
Battling Counterfeit Medicines in Africa: Leveraging Technology for a Safer Supply Chain

Battling Counterfeit Medicines in Africa: Leveraging Technology for a Safer Supply Chain

Nov 8, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Fake medicines kill almost 500,000 sub-Saharan Africans a year: UNODC report.
US DSCSA – Misalignment Exceptions

US DSCSA – Misalignment Exceptions

Oct 11, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Will the US DSCSA misalignment exception disrupt your supply chain?
WHY IS ITALY MOVING FROM BOLLINO SYSTEM TO EU FMD

WHY IS ITALY MOVING FROM BOLLINO SYSTEM TO EU FMD

Oct 4, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Italy's Transition from Bollino to EU FMD for pharmaceutical serialization and traceability: A Move Toward Safer and More Efficient Healthcare!
Insights from Indonesia's Serialization Pilot Project: A Comprehensive Overview

Insights from Indonesia's Serialization Pilot Project: A Comprehensive Overview

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

The pharmaceutical serialization initiatives in Indonesia have been part of a broader regulatory effort led by the Indonesian National Agency of Drug and...
Preparing for Serialization in Indonesia

Preparing for Serialization in Indonesia

Aug 23, 2024 | Serialization, Pharmaceutical, Regulations, Compliance

Introduction to Regulation
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    Recent Posts

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