Below you'll find a list of all posts that have been categorized as “Life sciences”
Imagine investing fifteen years or more in developing a promising new drug, only to have a simple labeling error derail your launch plans, or – even worse – result in a product being quarantined or recalled from the market. Unfortunately, this is not at all uncommon. FDA drug recalls are on the rise, increasing 65% over the last decade(Source: GS1), …
Digital transformation has taken the world by storm. An increasing number of companies are adopting cloud-first strategies with pandemic-driven remote work accelerating this transition. However, this step toward modernization comes with some challenges for regulated companies. The myriad of labeling guidelines, along with the requirements and regulations that life sciences companies face can be overwhelming. What’s more, they’re constantly changing …
The medical device industry is poised for growth in the coming years. This presents opportunities for many, but also immense challenges and greater strain on the supply chain. And considering that the medical device industry is highly regulated, these companies also have to pay special attention to varying requirements across borders, lengthy approval processes and non-compliance penalties – all of …
Mergers and acquisitions are all too common for pharmaceutical manufacturers. While the combination of two companies has its benefits, it doesn’t come without growing pains and challenges. Take for example, labeling. A merger can result in decentralized labeling processes with inherited home-grown systems and a new array of third-party suppliers, contract manufacturers, re-packagers and re-labelers. It can also lead to …
The EU MDR one-year delay gives you the opportunity to take a more measured, strategic approach to compliance. However, it’s important to use the time wisely. In this blog, we highlight five steps that will help you on the road to UDI compliance. We’ll also talk about how to review your existing labeling processes and ensure you’re using the best …
The postponement of the EU MDR deadlines has given medical device manufacturers a unique opportunity to digitize quality assurance as they take steps to comply with MDR requirements. By seizing this opportunity, MDMs can simplify the compliance process, ensure greater label accuracy and, ultimately, get their products to market faster. If you’re facing the EU MDR deadline, the last thing …
FDA Class I just the beginning There is a wave of regulations hitting medical device manufacturers (MDMs) with international operations. In addition to the upcoming deadlines for US FDA Class I and the EU MDR date of application, the in vitro diagnostic regulation (IVDR) date of application goes into effect in May 2022. After that, there are a number of other application …
“Without having a standard solution, it made it pretty difficult to control, or to have an overview of all the technologies and labels that were used and printed at our different production lines. We had a lot of different label templates and different solutions for printing labels.” This is how Pierre Rahm, IT Operations Services in Boehringer Ingelheim described the …
We are seeing pharmaceutical supply chains digitizing across the world. It is a process that involves the implementation of AI, big data analytics, large-scale automation, digital twins and a plethora of other technological advancements that are helping to revolutionize the whole industry by breaking down siloed processes, departments and facilities. Yet despite all the focus on digitization, many companies have …
On September 25, 2019, NiceLabel hosted an event at Medicon Valley Alliance in Copenhagen, Denmark. The day’s theme was best practice in label management: from solution selection and implementation, to integration and process improvement. The presenters shared their knowledge and experience in how to best handle labeling in a regulated environment. Chr. Hansen shares their label transformation journey The first …
