New Approach Methodologies (NAMs)
The EMA, FDA, and US EPA are looking to reduce unnecessary animal testing, which involves replacing in vivo animal studies with in vitro and in silico methods to determine the toxicity of a substance. SAXOCON welcomes this focus on enhancing animal well-being while...
FDA CGMP Requirements Incorporating ISO 13485
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...
Unexpected Findings in Production
Are you responsible for the production of pharmaceutical products such as vaccines? What if you suddenly find something unexpected, like some foreign material or particles in one of the vials you produce? Sudden unexpected findings of particulate matter in or in...
Food Contact Materials Biosafety
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...