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Regulatory Affairs


Start up new projects for development

Worldwide expertise in regulatory affairs

Sample analysis, stability studies, development of new analytical methods

Microbiological tests for evaluation of bactericidal fungicidal and yeasticidal activities



De regulatory affairs departmet of CIRLAM laboratory stands for:

  • Development 

  • Reglementation 

  • Environment 

  • Assistance 

  • Marketing 

  • Solutions

We offers expertise in regulatory affairs worldwide and is based in Belgium. The regulatory requirements become increasingly complex, and it’s important to find the best approach for regulatory struggles. Beside the European legislations each country has its own national approach and requirements. This and new, more strict legislations give a high level of complexity to regulatory affairs. 

For a company it’s important to have a good strategy for their whole product range. Each product is different and has its own issues. It can make the difference for marketing of chemical products in a safe and legal way. 

Communication with regulatory authorities: 
We have developed a good relationship with the competent authorities worldwide in order to get good advice during the registration process of a product. In case the competent authority asks for more information or has questions, we make a quick and adequate answer. 

We can guide you through the maze cost-effectively. We have expertise in: 
1. Detergents, cleaning products 
2. Disinfectants, biocides 
3. Veterinary medicinal products 
4. Cosmetics 
5. Feed additives 

We prepare the registration files for submission to the authorities and we follow it until the product is authorized.




The most important role of the R&D department is to start up new projects for development of new animal pharmaceutical products, new biocides and new cleaning products. CIRLAM Laboratory looks at the feasibility of these projects. This from the production and the quality assurance to making a good cost/ benefit analysis. 
The R&D department provides accreditations that are recognised by customers and authorities: providing microbiological testing and chemistry data and registrations conform to the REACH regulations. 

The R&D team plays an essential role in aiding the technical and sales departments of a company. We make sure that there is a perfect collaboration with the production so that the formula of a product can be produced with or without the chosen specific equipment for its production 

At CIRLAM Laboratory we look for (new) innovations to fill gaps in the “open market” of our working area. We search for proper and practical and easy to use product solution for your hygiene problem.



Chemistry laboratory has three principle activities: 

 1. The first activity is the analysis of a sample meaning that the physical properties of a sample can be determined using a large quantity of techniques like the measurement of pH, density, viscosity, UV/Visible spectrophotometry, Infra-Red spectrometry. The quantities of chemicals can also be determined in a sample and this while using highly precise equipment such as Head space/gas chromatography and HPLC using UV/Vis, Conductimeter and Evaporative Light Scattering Detector 

 2. During stability studies physical (pH, density …) and chemical (titration of active substance) characteristics can be determined of the product that is placed in stability. These products are analyzed regularly in time and are placed in certain conditions of storage (temperature, humidity …). These tests are done to simulate the different condition that a product can meet in its life. 

 3. The last of are principle activities is the development of new analytical methods. New product or new active substance need to be quantified. Chemistry laboratory develops using the right equipment and validates the analytical methods. A method which is validated is repeatable, linear, robust and precise and guaranties the exactitude of the results.


The microbiology lab has 3 main activities 

Microbiological tests for evaluation of bactericidal fungicidal and yeasticidal activities of chemical disinfectants and antiseptics regulated by a set of European norms. The most common norms are: 
o EN 1040 
o EN 1275 
o EN 1276 
o EN 1650 
o EN 1656 
o EN 1657 
o EN 13697 
o EN 13704 
These European norms (written international procedures) take account the practical circumstances and applications of the product: contact time, temperature, test organisms and interfering substances. All conditions that can alter the proper function of the product in practical situations (in vivo) is reconstituted in vitro. These conditions are defined so that comparison is possible between different labs and different product types. 
Each of the in vitro requested concentrations of the chemical disinfectant or the antiseptic in this test matches a certain test condition in real life. It is possible to alter any of the above quoted parameters oft the European norm. In this case you can use any strain you want to test in stead of the standard microorganisms stated in the European norm. The microbiological lab of CIRLAM Laboratory can also execute AFNOR, AOAC and DLG tests. Please feel free to contact us to obtain more information about this subject. 

 In another part of the microbiological lab, we conduct routine sample analysis. In fact, in many parts of the food industry, there is a constant demand for the control of proper hygiene. Special methods need to be used to gather samples in a correct manner. Taking a water sample, contact plates and swabs are the most conventional techniques for examining the hygiene in specialized work areas. When receiving these samples, professional laboratory of CIRLAM Laboratory, can determine several parameters, including: 
o Total count 
o Total bacterial count 
o Total fungicidal count 
o Enterococci count 
o Coliforms 
o Salmonella 
o Listeria monocytogenes 
o Etc... 


In collaboration with the chemistry department, we participate to the development of new products for our clients.


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