Select Page
Celebrating Arla’s BLG Novel Food Application Success

Celebrating Arla’s BLG Novel Food Application Success

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...
New Approach Methodologies (NAMs)

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

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

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

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...
Biosafety and In-Vitro Diagnostics

Biosafety and In-Vitro Diagnostics

Do you manufacture in-vitro diagnostic medical devices? If so, you will need a CE Mark certificate to market them in the EU. A CE certificate verifies the biosafety of your products and that they perform as intended. Regulations such as (EU) 2017/746 (IVDR) Annex I...