Regulatory intelligence & strategy
Given their novelty, biotechnology products and technologies, especially those related to microbiome modulation, do often not fit within established regulatory categories of food or pharmaceuticals. At any stage of a product’s lifecycle, and starting from its inception, we can help you find the best way to develop or classify your products for an optimal market entry in the EU and the US, and subsequently undergo the regulatory procedures necessary.
Also, in the EU, most Member States impose specific rules on what food ingredients can be sold and to what limits, and hence product formulations may need to be altered to meet these requirements and sell in the EU. We have extensive experience in reviewing and adapting product formulations to meet EU and national standards. Lastly, emerging from the stringent EU regulation on nutrition and health claims made on foods, product labels need to be generated or adapted following specific rules regarding both content and format, which we also routinely do for our partners.
In the US, innovative food ingredients such as novel probiotic strains and certain prebiotics may need to undergo certain regulatory procedures. These involve technical and regulatory steps that we can also help you with.