What are the requirements for marketing a probiotic or postbiotic strain?
Developing supplements or functional foods containing a biotic strain involves much more than simply demonstrating their effectiveness. This process is essential for obtaining regulatory approvals from authorities such as the European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) :
Our response: A comprehensive analytical offering aligned with regulatory expectations
GenoScreen supports you at every step with a tailored analytical offering, based on our experience in genomics, molecular microbiology, and European regulations:
Stability
Genetic stability control
Verify strain consistency over time
Deliverables
Standardized reports adapted for EFSA/FDA
Facilitate your regulatory submissions
Our experts know how to translate scientific data into clear and actionable regulatory deliverables to ease communication with authorities.
GenoScreen focus: iQuant, our solution for monitoring, traceability, and viability of your strains
Our iQuant solution is based on a strain-specific qPCR. It allows:
- Absolute quantification of a target strain in a product or complex sample
- Stability control between batches
- Verification of strain persistence in vivo
- Distinction between live and dead cells (via PMA treatment)
iQuant integrates seamlessly into:
- Clinical trials
- Stability studies
- Quality certification and regulatory processes
We support you in designing your analytical plan, interpreting results, and preparing your deliverables.
A solid scientific approach
Deliverables aligned with regulatory expectations
An expert team at your side
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Find out more about our articles on biotics.
How to prove the efficacy of a probiotic or postbiotic using genomics?
Biotics — whether prebiotics, probiotics, or postbiotics — are at the core of nutritional and therapeutic strategies aimed at preserving or restoring gut microbiota balance. However, with increasing regulatory requirements (EFSA, FDA) and growing market competition, it is crucial to demonstrate their efficacy through robust scientific evidence...
From prebiotic to LBP: Measuring functional effects in the gut microbiome.
An imbalanced microbiome is not only characterized by a lack of diversity or abundance of species. What truly matters are the functions expressed...