by Zeeshan | Sep 11, 2026 | Serialization, Track and Trace
by Zeeshan | Aug 7, 2026 | Serialization, Track and Trace
by Zeeshan | Jul 3, 2026 | Serialization, Track and Trace
by Zeeshan | Jun 19, 2026 | Serialization
The European medical device regulatory landscape reached a major milestone in 2026. After years of phased development, the European Database on Medical Devices (EUDAMED) has moved from a largely voluntary platform to a mandatory regulatory system for key activities...
by Zeeshan | Jun 5, 2026 | Serialization
The Next Serialization Challenge Is Not Technology…It’s Economics Over the past decade, pharmaceutical manufacturers have invested heavily in serialization programs to comply with regulations across major developed markets such as the United States, Europe,...
by Zeeshan | May 1, 2026 | Serialization
The journey toward full compliance with the Drug Supply Chain Security Act (DSCSA) has fundamentally reshaped how pharmaceutical supply chains operate. As serialization, traceability, and verification requirements tighten, exception management has emerged as a...
by Zeeshan | Apr 24, 2026 | Serialization
A Practical Guide to UDI, Traceability, and Compliance The National Health Regulatory Authority (NHRA) is introducing a comprehensive medical device traceability and serialization framework that aligns Bahrain with global regulatory leaders. This initiative is not...
by Zeeshan | Apr 3, 2026 | Serialization
Among all global initiatives, Turkey’s Pharmaceutical Track & Trace System (ITS – İlaç Takip Sistemi) stands out as one of the earliest and most comprehensive implementations. Launched over a decade ago, ITS is often regarded as a pioneering model that many...
by Zeeshan | Feb 27, 2026 | Serialization
Indonesia continues to strengthen its pharmaceutical traceability framework as part of its broader strategy to combat counterfeit medicines and improve supply chain transparency. Since the implementation of Regulation No. 22/2022, the country has been moving steadily...
by Zeeshan | Feb 20, 2026 | Serialization
Serialization and track and trace systems are now core to pharmaceutical supply chain compliance and security globally. But internal management of these operations is costly, complex, and resource intensive, especially in multimarket environments. Offloading...
by Zeeshan | Feb 13, 2026 | Serialization
The Jordan Food and Drug Administration (JFDA) has made serialization using GS1 2D DataMatrix mandatory for all pharmaceutical products marketed in Jordan, with a firm compliance deadline of 1 January 2026. This requirement is part of a broader push to enhance drug...
by Zeeshan | Jan 23, 2026 | Serialization
Lebanon’s pharmaceutical market is governed by an active and enforced serialization and traceability regulation known as MediTrack. Overseen by the Ministry of Public Health (MoPH), this system mandates standardized identification and digital tracking of medicines...
by Zeeshan | Jan 15, 2026 | Serialization
The US Drug Supply Chain Security Act (DSCSA) has fundamentally transformed how pharmaceutical supply chains manage product traceability, data exchange, and verification. While serialization and EPCIS data exchange are now well understood, exception management has...
by Zeeshan | Dec 26, 2025 | Serialization
Pharmaceutical serialization and traceability laws are expanding rapidly. Previously limited to markets like the EU and US, many countries now enforce or plan mandatory systems to combat falsified medicines and enhance supply-chain transparency. Serialization is no...
by Zeeshan | Dec 19, 2025 | Serialization
Egypt is moving fast to secure its medicine supply chain. Over the past two years the Egyptian Drug Authority (EDA) has shifted from pilots and consultation to a formal national track-and-trace program that will require unit-level serialization, electronic reporting...
by Zeeshan | Dec 5, 2025 | Serialization
This blog provides practical guidance on the implications of Commission Decision (EU) 2025/2371 and outlines required actions for medical device stakeholders, especially non-EU manufacturers, preparing for compliance with mandatory EUDAMED module usage starting 28 May...
by Zeeshan | Nov 21, 2025 | Serialization
An independently authored analysis based on Kazakhstan’s national rules for medicinal product labelling and traceability. Brief Background Kazakhstan has implemented a comprehensive national system for tracking medicinal products throughout their lifecycle from...
by Zeeshan | Oct 23, 2025 | Serialization
In a landmark move for the country’s health sector, the South African Health Products Regulatory Authority (SAHPRA) has officially released the Traceability Guideline – Implementation Roadmap (Issue No. HPA16-2025/26). This circular outlines South Africa’s national...
by Zeeshan | Sep 25, 2025 | Serialization
The Jordan Food and Drug Administration (JFDA) has issued a new circular that sets a clear timeline for the mandatory implementation of DataMatrix serialization on pharmaceuticals. This directive is a significant milestone in Jordan’s pharmaceutical regulatory...
by Zeeshan | Sep 19, 2025 | Serialization
On 18 July 2025, the Medicines Control Authority of Zimbabwe (MCAZ) officially put into effect the Guidelines for Implementing Traceability of Medical Products in Zimbabwe (MCAZ/LED/GL-22). This landmark regulatory step is designed to combat falsified medicines,...
by Zeeshan Ahmed | Jul 19, 2024 | News
We are thrilled to announce that Cosmotrace has achieved the prestigious Great Place to Work® certification! This remarkable recognition underscores our unwavering commitment to creating a workplace where innovation, excellence, and employee well-being thrive. ...
by Zeeshan | Jun 26, 2023 | News
CosmoTrace Named Gold Winner in the 3rd Annual 2023 Globee® Awards for Disruptors London – 26 June 2023 – CosmoTrace is thrilled to announce that we have been honoured as the Gold winner in the prestigious 3rd Annual 2023 Globee® Awards for Disruptors in the...
by Zeeshan Ahmed | Jan 24, 2023 | News
CosmoTrace LLC is thrilled to announce the opening of its newest office in Dover, Delaware. We are expanding our global footprint to the USA, providing top-notch serialization and traceability services to the life sciences industry. As a leading global provider of...
by Zeeshan | Jan 4, 2023 | News
We are pleased to welcome Karl Waldman to the CosmoTrace team! Karl Waldman is an operational leader with a record of profitable revenue generation. And the introduction of breakthrough technologies. He has expertise in program and product management, operations and...
by Zeeshan | Jun 8, 2022 | News
In a bid to expand its business globally CosmoTrace, a leading Consulting organization that offers Serialization & Traceability strategy consulting, has set up a new office in Sharjah Media City (Shams), UAE to provide Traceability & Serialization...
by Zeeshan | Mar 20, 2022 | News
Happy to announce that CosmoTrace will be a satchel sponsor at the annual @GCC regulatory affairs pharma summit at Habtoor Grand Resort Dubai on 21st and 22nd March 2022. Visit our booth to say hello or if you would like to have a discussion about the ways...
by Zeeshan | Oct 29, 2021 | Serialization
Key dates in UAE for 2021December 13, 2021: Implementing the 2D barcode and serialization on the packsDecember 13, 2022: Serialization reporting and onboarding onto Tatmeen IntroductionRelating to the final version ( 10 August 2021) of serialization track and trace...
by Zeeshan | Oct 21, 2021 | Serialization
Key upcoming updates for Bahrain Traceability December 2021 – End of 90 day grace period to Invoicing Companies, MAHs and exporting distributors in submitting reports to the NHRA-MVC Traceability Hub. October 2021 – MAHs to be certified and reporting...
by Zeeshan | Oct 15, 2021 | Digital
The Evolution of Data The digital revolution has transcended new age gadgets and fascinating devices and has changed every industry and the pharmaceutical industry is no exception.Pharmaceutical companies are starting to adopt a business model with data as a...
by Zeeshan | Oct 8, 2021 | News
Matt Ricketson brings more than 30 years experience in professional services and business development. CosmoTrace, a management consulting company providing serialisation & traceability implementation services, has announced the appointment of Matt Ricketson as...
by Zeeshan | Oct 8, 2021 | Serialization
In today’s world of pharmaceutical serialization where we have dozens of different regulations and laws pertaining to pharmaceutical and medical device serialization across the globe, the Quality Person (QP), Quality Assurance (QA) or Quality Control (QC) team in the...
by Zeeshan | Oct 5, 2021 | News
London, UK. CosmoTrace, the leading management consulting company providing Serialization & Traceability implementation services announced a milestone year surpassing one million dollars in annual revenue. Since its inception, CosmoTrace has seen substantial...
by Zeeshan | Oct 1, 2021 | Serialization
Defining the basics Serialization is assigning a unique product identifier to the smallest saleable unit that can be uniquely verifiable. Tracking is understanding the current and past locations of a serialized unit. Trace is to identify the history of all entities...
by Zeeshan | Sep 24, 2021 | Serialization
Automation has revolutionized manufacturing by boosting production levels to meet increased demand in all industries. The pharmaceutical industry is no exception. The increased demand for vaccines for example has forced many pharmaceutical companies to do more with...
by Zeeshan | Sep 16, 2021 | Serialization
Introduction To avoid falsified medicines reaching the supply chain, European Medicines Verification Organization (EMVO) has designed a robust alerting functionality to track any potential falsified medicines that reach the supply chain. The EU FMD framework was...
by Zeeshan | Sep 10, 2021 | Serialization
With an increasing complexity in the pharmaceutical serialization regulation and supply chain requirements across the globe, project management has become an integral part of the pharmaceutical companies to manage their track & trace projects in an effective and...
by Zeeshan | Sep 3, 2021 | Serialization
Introduction The EU MDR is a new set of regulations that came into effect on 26th May 2021, following a 4-year transition period after being adopted in May 2017. It aims to improve the safety and performance of the device throughout the lifecycle by tightening up the...
by Zeeshan | Aug 27, 2021 | Serialization
The SFDA Dossier requirements differ for each application. What is important to note is that the CTD provides a format for an MAA (Marketing Authorization Applcication) Also to be noted is that regional and national requirements may affect the content of a...
by Zeeshan | Aug 20, 2021 | Serialization
SFDA is the regulatory body in Saudi Arabia that handles the registrations and approvals for products that are distributed in Saudi Arabia whether they are locally made or imported. All product placements in the market require an SFDA certificate to protect the market...
by Zeeshan | Jul 30, 2021 | Serialization
The past decade has seen major breakthroughs in technology and though there have been really great strides, the pace of innovation in technology is still on at an ever increasing pace. Here are some present and rapidly advancing supply chain technologies that you...
by Zeeshan | Jul 16, 2021 | Serialization
VRS or Verification Router Service is an automated way of verifying saleable returns to improve supply chain efficiency while maintaining the integrity of the supply chain and keeping it free from counterfeit drugs. What are saleable returns? When products are...
by Zeeshan | Jul 9, 2021 | Serialization
The epidemic has brought in a renewed effort in maintaining strict hygiene and safety standards keeping consumer safety in mind. It is needed for business owners to have clear visibility of the supply chain. Traceability plays an indispensable role in consumer safety...
by Zeeshan | Jun 24, 2021 | Serialization
Early Implementation In 2017 the Indonesian Food and Drug Authority (BPOM-Bedan Pengawas obat dan Makanan) began the initial implementation of serialization to fight the impacts of counterfeit drugs in the country. It, in turn, became the first ASEAN member state to...
by Zeeshan | Jun 17, 2021 | Digital
Of all counterfeit items that affect consumers adversely, counterfeit drugs have the most damaging impact. The production and sale of unregulated and falsified drugs has been a major issue in the pharmaceutical Industry. The directives of the goverments over the world...
by Zeeshan | Jun 4, 2021 | Serialization
Understanding Saudi Arabia’s Serialization and Aggregation requirements Introduction to the SFDA The Saudi Food and Drug Authority also known as the SFDA has created the standardized RSD identification system to track the...
by Zeeshan Ahmed | May 28, 2021 | Serialization
Brazil’s legislation has had a complex set of requirements for putting into effect their serialization and reporting processes in order to achieve complete compliance. Back in 2016, ANVISA signed the National Medicine Control System SNCM into law (Law No....
by Zeeshan | May 7, 2021 | Serialization
What is EU FMD? The EU FMD framework was initially put into place on 9th February 2019 to track any potential falsified medicines that reach the legal supply chain to ensure patient safety throughout the member countries. From that date onward, all products...
by Zeeshan | Apr 23, 2021 | Serialization
Focusing on manufacturing and packaging stagesHaving an organized and efficient serialization inventory is essential for organizations to manage the supply chain effectively. It becomes difficult to efficiently process the inventory in mixed environments that contain...
by Zeeshan Ahmed | Apr 16, 2021 | Serialization
The recently announced TGO 106 guidance by the Australian government department of Health provides guidance to sponsors and manufacturers supplying medicines in Australia. Even though serialization and use of data matrix codes at this time continues to be optional,...
by Zeeshan Ahmed | Apr 9, 2021 | Serialization
What is Aggregation? In short, aggregation is the undertaking of creating a hierarchic relationship between distinctive identifiers assigned to packaging containers. Companies have been complying with Serialization guidelines for a while now, i.e., the process of...
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