EFSA Regulatory & Market Access Consulting

CellMade provides turnkey technical and regulatory consultancy designed to de-risk market entry and accelerate Novel Food authorizations across the European Union. We bridge the gap between complex analytical data and regulatory compliance by authoring robust, audit-ready EFSA dossiers. By designing targeted, minimum-viable testing strategies that satisfy regulatory demands without wasting precious sample volumes, we eliminate compliance bottlenecks. From initial gap analyses to full technical submissions and QPS notifications, our expert regulatory team serves as a trusted single partner, ensuring your novel food innovations achieve swift, confident approval.

• Novel Food Dossier Preparation (EFSA): End-to-end technical dossier compilation, identity characterization, toxicological assessment, and formal safety submission packages prepared in accordance with EFSA scientific opinions.

• Toxicological & Safety Strategy Mapping: Designing smart, risk-based testing frameworks that strategically satisfy EFSA safety requirements while conserving client capital and minimizing novel biomass waste.

• EFSA Qualified Presumption of Safety (QPS) Dossiers: Full taxonomic verification, genetic safety profiling, and QPS dossier preparation for microbial cultures, biomass strains, and precision fermentation production hosts.

• Regulatory Gap Analysis & Peer Review: Expert pre-submission auditing of existing analytical datasets and regulatory packages to identify potential safety gaps, compliance risks, and data deficiencies prior to formal filing.