Firalis Group
FIRALIS is a biotechnology company located in the very heart of BioValley, on the true triple border of FR-DE-CH, only a few minutes walking distance to Basel, the pharmaceutical capital of Europe. Firalis creates novel values via biomarker discovery, development and regulatory qualification and brings to market biomarker-based diagnostic products. With a comprehensive expertise in the field, Firalis develops diagnostic kits and provides an extensive range of biomarker services; to improve therapeutic decisions as well as disease outcomes and patient comfort, finally to reduce healthcare costs at remarkable extents. Activities of Firalis mainly but non-exclusively involve biomarkers of inflammatory disorders such as atherosclerosis, rheumatoid arthritis, rare/orphan diseases such as systemic or autoimmune vasculitis. A major part of our activities cover drug-induced organ injuries in particularly kidney, liver and vasculature, as major drug targets.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Pharmaceuticals
- Market Focus:
- Globally (various continents)
Welcome
Why Firalis
Firalis provides a comprehensive range of biomarker services from research to clinical qualification. Stratification at scientific and technical levels support biomarker discovery, validation, evaluation and qualification. Using our strong expertise and cutting-edge laboratory equipment, we develop and deliver customized solutions for biomarker assays according to your project needs.
Who we are
Firalis is involved in several large scale projects for qualification of biomarkers in various clinical applications and led the efforts to improve industry standards, as the initiator of the SAFE-T consortium, largest ever biomarker research project co-funded by EU-IMI and Pharma.Today, Firalis validates and develops biomarker panels, following strictly the EMA and FDA directions.
What we do
Firalis' bioanalytical tools are developed in a GMP compliant production facility certified with 'ISO 13485', the international norm for medical device manufacture and biomarker services are performed in laboratories certified with 'ISO 17025', the most important quality standard for calibration and testing.
About Us
Firalis acquired its pioneering leadership in translational biomarkers to its unique network of clinicians and clinical centers of excellence that it built step by step, since 2008, thanks to many R&D consortia it coordinated, consisting partners from the European Academia (mostly University Hospitals), Big Pharma and other SME with complementary know-how. For numerous of its R&D projects, Firalis has been awarded with research and entrepreneurship awards as well as significant research grants which allowed us to conduct some of the largest clinical biomarker studies ever.
At Firalis, we exclusively invest on projects with highest potential of success, commercialize constantly new products, and target to launch a high-value in-vitro diagnostic kit of our own.
Quality is Standard at Firalis
At Firalis, continuous development is an objective, and all our employees are actively involved in the efforts to maintain and improve the established quality standards, by participating actively in the company Quality Management System (QMS). Firalis operates under and is complaint with the following standards :
- ISO 9001 : Quality management system
- ISO 17025 : Calibration and testing laboratories
- ISO 13485 : Design and manufacture of medical devices
- NF S96-900 : Maintenance of biological resources
- GCLP 'Good Clinical Laboratory Practice'
- Next.. CLIA* 'Clinical Laboratory Improvement Amendments' (*compliance efforts ongoing)