Pharmaceutical regulatory procedures in the EU
Due to their intended use and other factors, some biotechnology and microbiome-modulating products and technologies may be regulated as medicinal products in the EU. Given the complexity of these products and the lack of specific regulations, these developments can be extremely challenging.
Sandwalk can support your business in contacting the European Medicines Agency through their Scientific Advice and Protocol Assistance procedure, designed to assist drug innovators in their development efforts. If your company is based outside the EU, Sandwalk can act as your point of contact or representative in the EU.