Regulatory affairs

BaseClear can help you acquire 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 generate 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 for the use of microorganisms as a 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.

Case study: Proving a negative with genomics

Getting a new animal feed product approved for sale in the European Union can be a minefield. Trouw Nutrition approached BaseClear: to support in specific guidance on proving the non-GMO status of a strain used to make a vitamin for the organic feed market.

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Meet Adalberto Costessi!

Adalberto Costessi enjoys working on the interface between technology and its application in his position as Product Manager Genomics and Regulatory Affairs. Adalberto’s roles and responsibilities include Regulatory Affairs projects, and shaping and developing new products using NGS sequencing platforms. His work in Regulatory Affairs has assisted many multinational clients in the food and feed industries draft dossier submissions for regulatory approval and has built up considerable experience in this area. He ensures that the generation of genomics and bioinformatics data are compliant with regulatory requirements and are suitable for supporting dossier preparation for new products based on microbial strains introduced intentionally into the food chain. He has extensive expertise in the technology side of genomics and brings a lot of technical knowledge into his position.

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