According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that their selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These...
The FDA Modernization Act to end animal testing has passed the US Senate. This change nullifies the old mandate requiring animal testing of all new drugs, thereby increasing the acceptance and use of Quantitative Structure-Activity Relationship (QSAR) and read-across...
Are you a pharmaceutical manufacturer? Do you know whether your products contain nitrosamine impurities and, if so, whether they are below the thresholds established by the various regulatory agencies? SAXOCON has the expertise and services necessary to help you to...
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...
