/ Validation of in vitro diagnostic methods and tools

Analysis, test and research laboratory

Laboratoire IVDR - ISO 17025

Who are we?

Welcome to Amarok Biotechnologies, your trusted partner for accelerating and securing your development. As an analysis, test and research laboratory, we are pioneers in biotechnologies applied to in vitro diagnostics. We operate in the medical devices (DM-DIV), food safety and environmental sectors, offering you customized support.

/ Activities of our biotechnology laboratory

Performance Testing and Evaluation Laboratory

Opt for a maximum level of regulatory compliance for the validation of your medical biology machines and reagents (IVDR). Our laboratory is ISO 17025:2017 accredited for the evaluation of in vitro diagnostic medical devices (DM-DIV).

Food hygiene control and environmental

Entrust your microbiological analyzes and your HACCP control to an independent laboratory in the countries of Saint-Malo and Dinan.

Research and development

Outsource your research and development programs, benefit from support and advice for your R&D strategy.

• Hosting of research and development programs on behalf of third parties.
• Advice and support in the development of your research.

Œnological products

Control and analyze fermentations thanks to our innovations developed with our partner Q-Wine.

Charm Sciences

Benefit from our technical and scientific support for the use of rapid test kits and systems for agri-food and the environment Charm Sciences.

/ Why use Amarok Biotechnologies?

Reliability

Specialists in evaluating the performance of in vitro diagnostic medical devices (DM-DIV) before they are placed on the market, we are also the first French laboratory accredited ISO 17025:2017, for this type of activity. With us, you will have the best guarantee of compliance with the requirements of the new European regulation 2017/746 IVDR or the regulatory authorities.

Innovation

We are the first in the world to have developed and marketed an immuno-cytometric method for diagnosing fermentation contamination for the wine industry. Our Brettanomyces yeast detection test remains unique internationally.

Trust

We are the representative in France of Charm Sciences Inc, the world leader in rapid tests for the detection of antibiotic residues in milk and for the safety of food production processes.

Acknowledgement

We have developed a solid institutional, associative and private partnership network, both locally and internationally. BPI, Brittany Region, European Enterprise Network

/ Our areas of intervention

/ Who can benefit from our services?

Biomedical industries (laboratories, startups)

Our services are aimed at IVD manufacturers and, more broadly, all players in the in vitro diagnostics sector (importers, distributors, regulatory affairs or quality management professionals). We provide expert performance evaluations (ISO 2017/746) for IVDs. We also provide solid, personalized R&D support for laboratories and innovative startups.

Restaurants and caterers

Restaurants and caterers find in our analytical laboratory tailor-made answers to their needs to guarantee food safety. We carry out hygiene checks and food analyses, and advise on regulatory issues.

Marine cultures

For aquaculturists (crustaceans, mollusks, etc.) and shellfish farmers (oysters, mussels, clams, etc.), we offer customized microbiological control solutions. Seafood products must meet some of the most stringent quality and safety standards.

Wine industry

We support the wine industry - winery owners, technical departments and wine analysis laboratories - in very specific ways to guarantee premium product quality. We are constantly innovating to improve control performance and process monitoring.

Dairy and cereal industries

The food industry, and more specifically the dairy and cereal sectors, benefit from our sales and technical support for Charm Sciences products. As the brand's sole representative in France, we help them to select and use rapid test kits and equipment for controlling food contaminants.

/ Our partners

/ They trust us

John Doe

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John Doe

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/ Resources

Contact us

Would you like to request a quote or discuss your projects?

Contact us​

Would you like to request a quote or discuss your projects?