FeyeCon has an important focus on compliance. We know the rules and we apply them. The first compliance is our technology itself, it is clear that we know the rules of designing and operating a safe apparatus. The most obvious rule in that case is the use of pressure in the CO2 industry. We comply with the American Standards (ASME rules) and the Pressure Equipment Directive (PED 2014/68/EU). If necessary we adopt them to the local guidelines, because each country often has slightly different rules and an own regulatory body. Our equipment is checked by an independent Notified Body (NoBo). We are also familiar and comply with explosion rule when using flammable. Both for the equipment ATEX 114 and the workplace ATEX 153. To put it differently, we know what equipment we are building and take the safety of our users extremely serious.
Especially in the pharmaceuticals space, rules and regulations are strict and complex. It is for this reason that we employ a Quality Assurance Manager, who is independent and navigates us through the rules of pharmaceutical productions for API’s and/or clinical batches for phase I, phase IIA/IIB and phase III trials. We are pharmaceutical GMP certified since 2006 and have been producing on a commercial scale for clients since 2007. Next to our GMP license, we hold an opiate license that allows us to research, develop and sell. All these activities are monitored by our QA Manager with a proper QA system in place. Putting product and eventually patient safety first.
We produce food grade products according to quality standards and will go the extra mile when of importance. In line with this philosophy, a Novel Food Application for the broad-spectrum CBD oil is being conducted through Folium Europe according to the legislation set by the UK Food Standards Agency (FSA). In parallel, a submission to the European Food Safety Authority (EFSA) is also being prepared. We are convinced that in the end only product that have been tested and safely produced will survive in the B2C market.
