Bioproduction · Biobanking · Clinical research
Firalis,biomarker-based diagnostics from Huningue.
Firalis specialises in biomarker detection. We develop in vitro diagnostic tests adapted to your biomarkers. The entire life of your product can be handled at Firalis, from the supply of critical compounds to sample biobanking, clinical studies and regulatory affairs, to bring your product to clinical diagnostics markets.
Products & Services
Bioproduction
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Critical products
Antibodies · Proteins · Enzymes
Supply chain
The production of both RUO and IVD kits relies on the supply of critical components. Firalis develops, validates and produces antibodies, standards and enzymes by biotechnological means, in high-quality grade, removing the discontinuation, customs, logistics, stock and scheduling risks of the supply chain.
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Kit production
Kitting
Both RUO and IVD kits are produced at Firalis following ISO 9001, ISO 13485 and ISO 14001, guaranteeing traced and reproducible product performance from batch to batch.
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Sales
Distribution
Firalis supports kit storage, stock logistics, product transportation and sales. Stability studies can also be run at Firalis to determine optimum storage conditions and transportation costs.
- Biomarkers
- Product validation
- Regulatory technical file
- IVD market
Regulatory affairs
Firalis offers regulatory affairs support, preparing and filing the dossier all along the development of your product, for both CE-IVDR and FDA markets.
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Products
Our expertise revolves around immunoassays, molecular biology and hybrid principles.
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Biobank & clinical studies
For biomarker discovery and validation, and throughout clinical studies, clinical samples can be stored in our ISO 20387 certified biobank.
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Research & development
Clinical studies we sponsor, and European consortia we coordinate or join, since 2009.
About Firalis
About Firalis SAS-
- Biomarker
- Industrialisation
- Clinical application
Why Firalis
We will be able to translate your biomarker into an industrial product for clinical applications.
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2016SAFE-T consortium
Who we are
Our projects aim to qualify biomarkers for clinical use. Firalis initiated SAFE-T, a European consortium whose liver-safety biomarkers earned FDA and EMA letters of support in 2016.
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- ProductionCertified
- TestingAccredited
- BiobankingCertified
Reliable services
Our production facilities are certified ISO 13485 for medical device manufacture, our testing is accredited to ISO/IEC 17025, and our biobank is certified ISO 20387.
Firalis SAS
Biomarker experts
- Since
- 2008
Media
All mediaRecent news
Firalis launches its Healthy Volunteer Clinical Study (HVCS)
Firalis SAS, sponsor of HVCS, welcomed its first volunteer on June 18, 2025. The study tests biomarker stability in blood, urine, saliva and buccal cells.
ONCOSCREEN partners meet in Kaunas to advance risk-based colorectal cancer screening
The European project held its second plenary meeting in Kaunas, Lithuania. Firalis leads biomarker identification and the clinical trial work.
Firalis joins VOLABIOS, a European project on the early diagnosis of schizophrenia
VOLABIOS started on January 1, 2025 with 18 partners from 11 European countries. Firalis contributes biomarker validation and its biobank.
Contact
Start a project with Firalis
Share your study, your sample request or your biomarker with our teams in Huningue.