Regulatory affairs

BaseClear offers full solutions to meet regulatory requirements, assisting you in overcoming challenges and facilitating entire projects, including genomic characterization of microbial strains and drafting dossier reports ready for EU/EFSA and/or FDA submission. We specialize in obtaining safety assessment dossiers for various microorganisms utilized in production strains, probiotics, live biotherapeutics, novel foods, and feed additive production through fermentation, among other applications in the food and feed industries.

Save up to € 2800 on strain safety assessment services in April!*

Save:

  • € 600 / test – Absence of viable cells
  • € 800 / test – Antimicrobial susceptibility (MIC) testing
  • € 1000 / test – Detection of DNA in final product
    Receive a € 2800 discount when you combine all three services.

*Sample must arrive at BaseClear no later than April 30th. Results will be delivered within 4 weeks.

Probiotic and production strain characterization

For nutrition or health claims the Food Safety Authority (EFSA or FDA) requires full knowledge of the organism you are working with. BaseClear can facilitate this with a complete genome-based strain characterization service, including copy number and gene expression analysis. In additon BaseClear offers a unique antibiotic resistance gene screening based on a highly curated CARD database, and production strain analysis and annotation.

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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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