Whether you are a pharmaceutical or medical device manufacturer, you need to comply with several layers of guidelines and regulations to bring your products to market and keep them there. Having suppliers you can trust is crucial to your ability to concentrate on...
As a pharmaceutical manufacturer, you need to know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by various regulatory agencies. Nitrosamine impurities can be introduced at any stage in the supply...
Complying with EU Medical Device Regulation (MDR) is not optional. If you are a manufacturer, authorised representative or distributor of medical devices, you will need to ensure compliance with EU MDR. Non-compliance with biological safety requirements can result in...
SAXOCON congratulates Arla Foods Ingredients on the positive EFSA opinion regarding their novel food application for Lacroprodan® BLG-100. We are proud that our contribution helped get the application over the finish line and look forward to Arla receiving full EU...
We are on the verge to merge. Things in the regulatory space for medical device manufacturers are about to get easier. In a new proposal on Quality System Regulation Amendments for Medical Devices, The FDA has decided to harmonize their GMP requirement for medical...
Packaging is not the first thing we think of when we think of food. However, the biosafety of the materials used in food packaging impact the food contained within. So, it is essential to understand the health and safety consequences of the packaging. For more...
