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IVD Diagnostics & Medical Devices

Smaltis supports the implementation of your in vitro diagnostic solutions, medical devices and reagents, which provide high value in pathology diagnostics, research programs and improvement of molecular biology techniques in laboratories. You can rely on our experts to support you at every stage of your development, from research to efficacy controls and method validation.

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Your needs

In the framework of the development or validation of your diagnostic tools and medical devices contributing to improving human, animal, or environmental health, you are seeking customized in vitro services in microbiology and molecular biology to support your product development and enhancement projects at all stages. The Smaltis team and its laboratories are at your disposal to meet your needs with a rigorous methodology and the achievement of reliable results.

Your products

  • In vitro diagnostic kits
  • Pathology detection kits
  • Detection tools for research
  • Contamination analysis kits
  • Medical devices
  • Molecular biology analysis reagents and/or equipments

The approaches you work on

Whether you are developing immunochromatographic tests for resistance mechanism detection, diagnostic tests for mutation detection to provide tailored therapy for patients, tools for predicting responses to targeted therapies, rapid analysis kits for food contamination, antimicrobial wound dressings, vaginal microbiota rebalancing ovules, or qPCR devices and reagents, Smaltis is able to understand your needs and partner with you to find the most suitable solutions.

Our offer

At what stage are you?

DEVELOPMENT STAGES 1

RESEARCH & SETTING-UP

2

COMPARISON/QUALIFICATION

3

EFFICACY VALIDATION

OUR SERVICES

Assessment of the performance and specificity of tests and products,
Supply of clinical strains and genetic material,
Analysis of molecular signatures and biomarkers in clinical samples,
Study of properties concerning microorganisms

Detailed data analysis and scientific interpretation of raw results from the comparison of the performance of reagents and devices

External validation of efficacy to confirm the reliability of products and meet regulatory requirements

Why choose Smaltis?

Our solutions and expertise enable you to supply, enhance, and secure your data within a rigorous scientific framework. The development of tools and reagents for in vitro diagnostics and molecular biology experiments requires uncompromising commitment to result reliability and manipulation reproducibility. These strengths are at the core of Smaltis teams, providing their expertise and precision for obtaining robust data that you can rely on.

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They trust us

Testimonials and references

Thomas GLOUDEN
PCR Development Expert
UNISENSOR

As part of the development of a simple, rapid molecular test for the detection of certain pathogenic micro-organisms in milk, we needed to work with a company with expertise in microbiology. We were looking for a qualified and experienced laboratory to prepare calibrated microbial suspensions and purified genetic material from different bacterial species. By identifying Smaltis, we were able to fully achieve our objectives thanks to the expertise of their team. We now regularly rely on this trusted partner for our recurring needs.

Pascal MERTENS
R&D Director
CORIS BIOCONCEPT

As part of the development of rapid in vitro diagnostic (IVD) tools for detecting infectious pathologies in humans, we needed to evaluate the performance of new tests dedicated to the detection of bacterial antibiotic resistance mechanisms. We approached Smaltis, a company specializing in microbiology and molecular biology, and found them ideally suited to our needs. Smaltis made its expertise available to assess the efficacy and robustness of our tests on clinical strains with very specific antibiotic resistance profiles, compared with a molecular biology method. The results confirmed the sensitivity, specificity and accuracy of our test, and enabled us to meet regulatory requirements. For us, the Smaltis laboratory is an expert player on whom we can rely to support our developments and obtain the data we need to bring our tools to market.

Karine ROGET
Chief Scientific Officer
NEXBIOME

As part of our programs to harness microbiota to improve human health, we called on Smaltis to demonstrate the antimicrobial activity of our pharmaceutical product to combat vaginosis. Smaltis demonstrated great expertise and efficiency in setting up relevant protocols adapted to our objective, while coping with the complexities inherent in handling particular strains in equally complex environments. The energy deployed by the Smaltis team and their ability to adapt have confirmed our choice of this expert, on whom we can rely for our other projects.

Laurence RINGENBACH
Cell Biology Lab Manager,
Immunodiagnostic Reagents,
DIACLONE SAS part of Medixbiochemica

Smaltis is a long-term partner with whom we have established a privileged relationship. We work in highly complementary domains and collaborate regularly to provide a comprehensive offering to our clients, utilizing microbiology and molecular biology services that we specifically require. We engage them for services such as sample contamination analysis, production of competent bacteria, and preparation of suspensions of inactivated strains for the development of new monoclonal antibodies. A true bond of trust has developed, facilitated by the geographical proximity of our respective locations and easy communication with their teams, whose flexibility, tenacity in problem-solving, and quality of work are crucial for us.

Eric ROBINET
Founder and President
LYMPHOBANK

Specialized in the production of cell banks from blood, for research and patient use, we needed to rely on a microbiology company to ensure the absence of contamination in our products from the start of our preparations. Established at the time in the premises of the EFS, it was only natural that we turned to Smaltis, located a few steps from our laboratories. Their work approach and the reliability of their results were exactly what we were looking for, and for several years now, we have entrusted them with all our microbiological analyses. The growth of our respective companies led us to look for new premises... and it is with pleasure that we took over the premises of Smaltis, who then moved into the building just across the street! It is important to have Smaltis in our network of reliable partners with common values, to contribute to the improvement of health!

News and articles

Management of Microbiological Contamination: Identifying, Understanding and Preventing Recurrence

Microbiological contamination is not limited to a non-compliant result. In R&D development, quality control, an industrial process or biological production, it immediately raises concrete questions: where does the contaminant come from, is it isolated or recurrent, what is its impact, and how can its reappearance be prevented?

The response is not simply to identify the bacterium and then restart the process. To achieve lasting control of bacterial contamination, the investigation must be able to connect laboratory observations with the real operational context: samples, flows, raw materials, equipment, cleaning, disinfection and field practices.

At Smaltis, we approach these situations as a structured microbiological investigation: understanding the problem, isolating the contaminants, identifying and comparing the isolates, preserving useful material, and then testing appropriate prevention solutions.

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Skin Microbiome: Cultivating Rigor to Objectify Innovation

The skin microbiome is not mere scenery. It is a functional component of the skin, involved in protection against pathogens, immune dialogue, and the modulation of inflammation. It is a dynamic ecosystem shaped by subtle interactions between bacteria, yeasts, the host, and the environment.

Our approach is grounded in a simple conviction: understanding a microbiome is not merely about identifying it. It is about knowing how to culture it, interrogate it, and generate scientifically defensible data.

This is precisely how we approach the skin microbiome: as a complex ecosystem whose actors, dynamics, and mechanisms must be mastered before attempting to modulate its balance.

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The Story of a Microbiota That Became a Medicine

Once upon a time, in the hospitals of the twenty-first century, there was an infection that even antibiotics could no longer silence. An opportunistic infection caused by a bacterium called Clostridioides difficile, it often appeared in patients who were already vulnerable… and, above all, already heavily treated. Let us look back at the history of this infection, which gave rise to new therapeutic approaches.

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Probiotic Characterization: Demonstrating Safety and Substantiating Activity

Probiotics are often presented as a simple category. In reality, their characterization has become a demanding scientific and regulatory exercise. It is no longer enough to identify a species or to invoke a favorable history of use: the demonstration must now be conducted at the strain level, in a way that is consistent with the intended use, the target population, and the applicable regulatory framework. In the main reference frameworks, a microorganism can be qualified as a probiotic in the strict sense only if it is sufficiently characterized, safe for its intended use, alive at a relevant dose until the end of the product’s shelf life, and associated with a documented health benefit. [1,5,7,8]

The key question therefore becomes: what can we robustly demonstrate about its identity, safety, and functional activity? This is particularly true for new or poorly documented strains, for which taxonomy alone is not sufficient. The EFSA, GRAS, and Canadian frameworks converge on one central point: useful characterization is strain-level characterization interpreted in light of the final use. [1-6]

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Designing Bacterial Mutants: From Gene Editing to Robust Strain Engineering

The construction of bacterial mutants is a cornerstone of microbiology. Historically used to decipher gene function, it now plays an equally strategic role in bioproduction, biotechnology, and the development of therapeutic bacteria, where the engineered strain itself may ultimately become the final product.

This shift has profoundly changed how mutagenesis projects are approached. Today, the objective is no longer simply to modify a gene, but to design a strain aligned with its final application, operational constraints, and regulatory expectations.

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Lugdunin: the secret weapon of an indomitable bacterium

Once upon a time, an invisible battle was raging deep inside our noses. A microscopic battlefield, where bacteria fought relentlessly to defend their territory. Picture a small village of indomitable Gauls, surrounded on all sides… but instead of Romans, it’s microbes. And in this surprisingly strategic setting, a most unexpected antibiotic was discovered: lugdunin.

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2026: Taking on New Scientific Challenges Together

As we step into 2026, the entire Smaltis team sends you our warmest wishes. May this new year bring clarity, creativity, meaningful collaborations — and a few scientific breakthroughs that get the attention they deserve.

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Antimicrobial activity testing: measuring, understanding, and anticipating resistance

Every day, antimicrobials face their natural adversaries: bacteria.
But in this silent war, nothing remains static — bacteria learn, adapt, defend themselves… and develop increasingly sophisticated resistance mechanisms.
Smaltis is a microbiology CRO specialized in the study of antimicrobial resistance and the preclinical development of antimicrobials.
We support the developers of new antibiotics, peptides, biocides, and other anti-infective agents with a comprehensive panel of in vitro assays designed to meet the most demanding R&D challenges.

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Meeting the Innovation

Smaltis at the Key Industry Events of Autumn 2025! From medical devices to biotherapies, from fundamental research to industrial production, we meet project leaders to better understand microbiology needs and build new collaborations.

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New Offer Structure: 2 Business Units Supporting Your Projects

At Smaltis, our ambition remains unchanged: bringing microbiological excellence to your innovations.
To better address the diversity of your needs, we have structured our offer around 2 complementary Business Units, true pillars of our scientific and technical commitment.

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Let's study your project!

Are you interested in our services? Ask our experts to study your needs and design a tailor-made collaboration with you.

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