{"id":770,"date":"2024-04-10T15:16:10","date_gmt":"2024-04-10T13:16:10","guid":{"rendered":"https:\/\/www.genoscreen.fr\/regulatory-services\/"},"modified":"2026-06-10T12:18:08","modified_gmt":"2026-06-10T10:18:08","slug":"regulatory-services","status":"publish","type":"page","link":"https:\/\/www.genoscreen.fr\/en\/regulatory-services\/","title":{"rendered":"Regulatory Services"},"content":{"rendered":"\n

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Microbial related products are found everywhere, from the feed given to the animals, to the food<\/a>, or directly to the biofertilizers used in the soils of our farms<\/a>. And as safety comes first, in the fields of life sciences and biotechnology, regulatory compliance<\/a> goes beyond administrative formalities. <\/p>\n\n

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Contact us for more information<\/a><\/div>\n<\/div>\n\n

Regulatory dossiers stands as a cornerstone for ensuring the safety<\/strong>, efficacy, and quality of your products, while also fostering trust among consumers and regulatory authorities<\/strong> alike. In this ever-evolving and intricate landscape, the compilation and submission of regulatory dossiers become pivotal steps in the obtention of market authorizations<\/strong>. <\/p>\n\n

Navigating the regulatory landscape can be daunting, with complexities and nuances that demand meticulous attention to detail<\/strong>. As such, partnering with an expert in the field becomes not just advantageous but essential.<\/p>\n\n

Our regulatory offer applies to several cases, listed later, and offers several advantages:<\/p>\n\n\n

Expertise in microbial regulatory services<\/h2>\n\n

Throughout the years, GenoScreen developed its expertise in regulatory affairs to help its clients and prospects comply with the expectations of the regulatory bodies<\/strong>. We run dossiers compliant testing including genomic characterization<\/strong> 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 \u201cready to publish\u201d<\/strong> format, encompassing all necessary information with utmost transparency about methodology required for regulatory bodies such as EFSA<\/strong>, FDA <\/strong>or ANSES<\/strong>. <\/p>\n\n

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Feed Additives & Enzymes<\/h2>\n\n\n\n

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<\/strong> (EFSA<\/strong>). We help them by accompanying them in giving proofs of safety and writing in the rightful way their report. <\/p>\n\n\n\n

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\"Feed<\/figure>\n<\/div>\n<\/div>\n\n
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\"Food<\/figure>\n<\/div>\n\n\n\n
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Food Enzymes & Additives<\/h2>\n\n\n\n

Food industry uses Enzymes and Additives in their production process. In Europe<\/strong>, these products are under the EFSA <\/strong>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 <\/strong>compliant microbiological reports. <\/p>\n\n\n\n

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Probiotics<\/h2>\n\n\n\n

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. <\/p>\n<\/div>\n\n\n\n

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\"Biofertiliser<\/figure>\n<\/div>\n\n\n\n
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Biofertiliser & Biocontrol<\/h2>\n\n\n\n

We help our clients eager to access the French biofertilizer\/biocontrol market to perform analyses as intended by the ANSES <\/strong>authority (Agence Nationale de S\u00e9curit\u00e9 Sanitaire de l\u2019Alimentation, de l\u2019Environnement et du Travail<\/strong>). We provide all the expected analyses and prerequisites regarding microbiological safety to our client, to maximise their chances to obtain market authorisation<\/strong>. <\/p>\n\n\n\n

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Learn more<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n\n
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“Novel Food”<\/h2>\n\n\n\n

Novel Food is officially described by EFSA <\/strong>as \u201cfood that had not been consumed to a significant degree by humans in the EU before 15 May 1997\u201d. It needs of course an authorisation before being available for consumption in Europe, once again, it is granted by the EFSA<\/strong>. Our analyses fill all the prerequisites asked for the biological part of the dossier. <\/p>\n\n\n\n

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\""Novel<\/figure>\n<\/div>\n<\/div>\n\n
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Request a quote<\/a><\/div>\n<\/div>\n\n\n

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Download the brochure<\/h3>\n\n\n