BaseClear can help you aquire a safety assessment dossier on microorganisms used as production strains, probiotics, live biotherapeutics, novel foods, feed additive production and fermentation among other food & feed applications. Our solution is to generating appropriate whole genome sequencing & bioinformatics data compliant with regulatory requirements and help build the dossier with rigorous scientific justification to support the safety of strains introduced intentionally into the food chain. 

The European (EU/EFSA) and USA (FDA) regulatory bodies have now strict guidelines for submitting products. Obtaining regulatory approval to use microorganisms as food or feed additive or production strain can thus be challenging. Applying the strict guidelines and rules to e.g. the genomic data generated when analysing these microbial strains often presents both technical and interpretation challenges. BaseClear offers full solutions to meet the regulatory requirements. We help you overcome challenges and can facilitate the complete project, including the genomic characterisation of microbial strains and writing dossier reports ready for EU/EFSA and/or FDA submission.

Meet Adalberto Costessi!

Adalberto is our Product Managers Genomics & Regulatory Affairs. Adalberto graduated in Medical Biotechnology at the University of Trieste. He specialised in molecular biology and next-generation sequencing during his PhD at the Radboud University in Nijmegen, where he studied the transcriptonal mechanisms of cancer cells. Adalberto is BaseClear’s technical expert on short and long read NGS platforms, including the latest nanopore-based technologies, and how to best use them for specific applications.

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