Microbial related products are found everywhere, from the feed given to the animals, to the food, or directly to the biofertilizers used in the soils of our farms. And as safety comes first, in the fields of life sciences and biotechnology, regulatory compliance goes beyond administrative formalities.
Regulatory dossiers stands as a cornerstone for ensuring the safety, efficacy, and quality of your products, while also fostering trust among consumers and regulatory authorities alike. In this ever-evolving and intricate landscape, the compilation and submission of regulatory dossiers become pivotal steps in the obtention of market authorizations.
Navigating the regulatory landscape can be daunting, with complexities and nuances that demand meticulous attention to detail. As such, partnering with an expert in the field becomes not just advantageous but essential.
Our regulatory offer applies to several cases, listed later, and offers several advantages:
Our efficient methods and proven expertise speed up dossier submissions, helping you enter the market faster and seize commercial opportunities
your genomic regulatory tasks
to GenoScreen, freeing you to focus on your core business while we handle analysis,
data interpretation and dossier compilation
for you
Expertise in microbial regulatory services
Throughout the years, GenoScreen developed its expertise in regulatory affairs to help its clients and prospects comply with the expectations of the regulatory bodies. We run dossiers compliant testing including genomic characterization of microbial strains and efficacy testing such as impact studies for microbiome related products, and then we analyse the results and compile them in a “ready to publish” format, encompassing all necessary information with utmost transparency about methodology required for regulatory bodies such as EFSA, FDA or ANSES.
You will be provided with
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Feed Additives & Enzymes
For our clients producing thanks to microorganisms Enzymes or Additives for the Feed industries, in order to obtain European market authorisation, they require to go through a Safety (and Efficacy) evaluation process by the European Food Safety Authority (EFSA). We help them by accompanying them in giving proofs of safety and writing in the rightful way their report.
Food Enzymes & Additives
Food industry uses Enzymes and Additives in their production process. In Europe, these products are under the EFSA regulation to ensure their safety and efficacy. We accompany biotech companies eager to fill in dossiers when it comes to microbiological analyses by providing them EFSA compliant microbiological reports.
Probiotics
Food Industry is increasingly using Probiotics in their food products as we understand further day after day the impact of the microbiomes on health, and the importance to keep healthy microbiomes. We support our clients in their quest of obtaining a market authorisation for their probiotic strains.
Biofertiliser & Biocontrol
Novel Food
Novel Food is officially described by EFSA as “food that had not been consumed to a significant degree by humans in the EU before 15 May 1997”. It needs of course an authorisation before being available for consumption in Europe, once again, it is granted by the EFSA. Our analyses fill all the prerequisites asked for the biological part of the dossier.
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