Below you'll find a list of all posts that have been tagged as “regulatory compliance”
There’s no way around it. Regulators require that life sciences companies validate their solutions. At the same time, manufacturers are under pressure to streamline operations, reduce costs and increase efficiency to compete in a challenging market environment. In many ways, it might seem like a near-impossible task: spending the time and resources necessary to achieve and maintain compliance, while at …
As companies strive to improve their time to market, a common challenge is finding an efficient way to manage a plethora of label variations. Every product has different labeling needs, depending on industry, customer, etc., and these needs can change rapidly and unexpectedly at any given time. That means that it is crucial not just to stay on top of …
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 …
The COVID-19 pandemic has changed business as we know it in so many ways. In the food industry for example, manufacturers, restaurants and retailers have had to rapidly shift how they supply food to consumers. Changes have been implemented in the interest of safety, but the result has been supply chain bottlenecks that cause delays in getting food to it’s …
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 …
