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...
Every day people are exposed to chemicals from a variety of sources such as food products, cosmetics, clothing, medical devices, and medicines. EU regulations set requirements for testing chemicals for their potential to cause harm, be it through DNA damage, cancer,...
The deadline, 26 May 2021, for EU MDR is fast approaching. The Danish Medicines Agency (Lægemiddelstyrelsen) recently published guidance regarding the new regulations and their consequences for both industry and Danish authorities. Read their guidance here (Danish...
Whether you are manufacturing medical devices, pharmaceuticals or combination products, you will be using materials. Marketing your products in the EU requires that you ensure the quality and safety of the materials used in your products. Early and robust material...
March 31st is the deadline for the completing your step 1 risk evaluation on potential nitrosamine impurities in medical products. These highly toxic compounds, some of which are considered to be even more carcinogenic than currently established thresholds, are...
