We help you identify the optimal pathway for your novel food's approval, considering your product’s unique attributes and the current regulatory landscape.

Our experts meticulously prepare and submit your novel food application dossier to the European Commission, ensuring it is comprehensive, scientifically robust, and compliant with EU regulations.

We conduct thorough safety assessments and risk analyses, providing the necessary scientific evidence to demonstrate your product's safety for EU consumers.

Acting as your advocate, we liaise with regulatory authorities, including the European Food Safety Authority (EFSA), to facilitate a smooth evaluation process, responding to queries and addressing any concerns.

Beyond approval, we offer strategic advice on market access, labelling, advertising, and post-market monitoring to ensure ongoing compliance with EU regulations.

Our expertise extends to cutting-edge food technologies, such as cellular agriculture, precision fermentation, alternative proteins, and synthetic biology, ensuring your innovative products navigate the regulatory process successfully.

For many innovative food companies, the US market is a critical step in global commercialisation. Biosafe helps you translate EU-grade scientific rigor into US-compatible regulatory strategies without unnecessary complexity. 

We evaluate your ingredient, production process, and intended use to identify the most appropriate US regulatory pathway and risk profile.

Our experts support the preparation of GRAS dossiers, including literature reviews, exposure assessments, toxicological evaluations, and expert panel documentation.

If your ingredient is intended for dietary supplements, we help assess whether an NDI notification may be required and support the safety narrative and documentation needed for the submission.

We develop robust, science-based safety arguments aligned with US regulatory expectations, ensuring credibility with regulators, partners, and investors.

For companies targeting both markets, we help align safety data and regulatory strategies across jurisdictions, reducing duplication and accelerating global market access.