Our Blog
Our blog articles cover topics and discussions on serialization, counterfeiting and compliance
Saudi Pharmaceutical Serialization and Aggregation Roadmap for Vision 2030
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 entire...
How to best start preparing for Serialization in Brazil
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. 13.410)....
Serialization – Understanding Alert Management in EU FMD regulations
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...
Understanding the difference between Serialization and Track & Trace
What was the need for Pharmaceutical Serialization? It is estimated that Pharmaceutical companies across the globe face billions of dollars worth of losses annually because of stolen or counterfeit products. One of the measures the industry took to overcome this...
Handling Traceability issues caused by ineffective serialization
Initial focus on manufacturing and packaging stagesHaving an organized and efficient serialization inventory is essential for organizations to manage them. It becomes difficult to find solutions to efficiently run the inventory in mixed and non-serialized...
Newly Announced Serialization Changes by the Australian Government (TGO 106)
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...
Aggregation and its Importance to Pharmaceutical Companies
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...
Implications of Brexit on the UK Pharmaceutical industry
The United Kingdom voted to leave the European Union in 2016, but it wasn’t until December 24th 2020 that the details of trade between the two countries was solidified. On that date, the two entities signed a 1,250-page Trade and Cooperation Agreement...
A Primer on Alert Management Within the EU FMD Regulations
The EU Falsified Medicines Directive (FMD) puts in a framework to track any potential falsified medicines that reach the legal supply chain. Individual units are scanned at the dispensary to verify their legitimacy. In case of any verification failures, the...
5 steps to help you improve transparency in your supply chain
The plan you choose to improve transparency in your supply chain will depend on the risks in your business and what problems you wish to solve with the data you receive. For example, do you wish to ascertain the origin source of your raw materials? Do you want to...
How can Serialization Management enhance your Supply Chain?
The need for serialization One of the constant battles the pharmaceutical industry has to face, is to prevent counterfeit and falsified drugs from entering the market and putting the public’s health at risk. The fraudulent products and drugs may be manufactured in...
Avoiding Mismanagement of Master Data
Master data management (MDM) is one of the most effective ways to help manufacturers, wholesalers and prescriber companies to work together and ensure the data shared within the network is accurate and transparent. This set of data consists of the most current...
How does Blockchain Technology benefit Serialization?
Before we explore the benefits of Blockchain Technology in Serialization, it's important to quickly recap what exactly is this technology. Blockchain Technology is a network that is decentralized and it shares real time complex information with all the participants...
Securing the Manufacturing and Packaging Supply Chain in a Pandemic
Since the beginning of the pandemic manufacturers and packaging suppliers have been trying to meet the sudden surge in demands owing to Covid-19. There was an immediate need for PPE and other medical equipment all at once across the globe. This exposed many...
What are the Serialization challenges Pharma CDMO’s face?
With pharmaceutical supply chains growing longer, it has become necessary to incorporate serialization in companies. The issue of counterfeit goods in the market has been a global issue for decades, more so now with longer supply chains and higher demands for...
Celebrating a Milestone!!
We are delighted to announce that CosmoTrace has reached an exciting milestone - 1500+ followers on LinkedIn and we could not be more pleased. A huge thanks to all our followers for contributing to the group by sharing, liking and commenting on the posts. We...
What is the Serialization Impact for Pharmaceutical Companies in the future?
Serialization has become a necessity for pharmaceutical companies and many countries like UK, USA, Italy and India have adopted different levels of serialization in their pharmaceutical supply chains. There are a host of reasons why serialization is being mandated...
Digital Traceability technologies may be able to help in the Pandemic against virus spread
When the Coronavirus initially spread across the globe, governments tried to contain it and prevent increasing cases. Supply chains were impacted because of the increased sudden demand of medical products and equipment which led to a lot of counterfeit products...
CosmoTrace expands footprint in APAC with a new office in India
The new year comes with a new beginning for CosmoTrace. CosmoTrace continues to grow and expand its operations with a new office in Hyderabad, India. "In a time of globalization, an international footprint is increasingly important and the decision to...
How can track-and-trace solutions contribute to ROI?
Tracking-and-tracing of products takes into account supply chain efficiency and also looks at completely functional solutions that target customer pain points for organizations. Track-and-trace solutions, especially digitally, don’t just add value towards a...
What CMO’s Should Know About Serialization And Aggregation
A safe, secure and effective supply chain needs to be transparent and have all the supply chain partners to work in tandem inorder to track, trace and verify authenticity of products. As Serialization aids in meeting these objectives through assigned unique...
How organized crime can impact Covid-19 vaccines
In our previous article we looked at the impact of counterfeit drugs affecting the pharmaceutical industry during the pandemic. We’re going to explore this a little deeper in this article and see how organized crime is impacting Covid-19 vaccines. We have been...
Counterfeit Drugs during COVID-19
During this global pandemic, counterfeit drugs hit the market and seem to be growing even now at an alarming rate. Although battling such faulty products has been a priority for manufacturers and suppliers, the industry is seeing a wide spread of and huge amounts...
MHRA guidelines to keep in mind for Northern Ireland post Brexit transition
Although the Brexit Transition period ends on December 31 2020 at 11 pm in the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) believes the exchange and circulation of medical goods may continue till January 1 2021 (as per their update on October...
What are the Current Trends in Regulatory Compliance?
Regulatory and compliance teams faced immense pressure after Covid-19 spread across the globe. The life sciences industry was trying to inculcate regulatory changes however, the pandemic expedited the need to put these into effect and to address all the new...
How to drive Successful Serialization in the Supply Chain?
The pharmaceutical industry has been able to prevent excess flooding of counterfeit and harmful products in the supply chain by ensuring compliance measures for serialization and traceability processes are followed. By implementing unique identifiers (such as...
How can the pharma industry prepare for Brexit?
The deadline for Brexit is nearing (December 31 2020) and the industry is anticipating some new regulatory rules and possible disruptions with exports and availability of products. This could have potential lasting effects as the healthcare industry continues to...
Serialization Challenges and Opportunities for Businesses
It is well known by now that counterfeit medicines can be extremely dangerous and a tremendous health risk for patients. It is one of the biggest battles Pharma companies continue to face irrespective of their location and size. The measures that the industry took...
How have Pharma Supply Chains changed post Covid-19?
When Covid-19 began spreading across the globe, pharmaceutical supply chains were put through tremendous strain but still managed to keep producing products amidst the crisis thanks to the operational and procurement teams. Even though drug shortages continue to...
Are you ready for Saudi Arabia’s aggregation requirements?
Are you ready for Saudi Arabia’s aggregation requirements? Saudi Arabia didn’t have an efficient process to track human registered drugs manufactured or imported from the country until the set up for the SFDA (Saudi Food and Drug Authority) which established the...