RESEARCH AND DEVELOPMENT LABORATORY IS CONSIDERED AS THE BACKBONE OF OUR COMPANY: IT WAS BORN IN 2016 AND, JUST ONE YEAR LATER, IT COMPLETED OUR FIRST SELF-TEST.
The research process is the result of a careful and continuous analysis of the scientific literature, combined with constant collaboration with laboratories, hospitals, universities and companies throughout Europe. Our R&D department is also responsible for offering consultancy and evaluation on projects and products, thanks to the expertise and know-how that distinguish our team.
Over the years we have developed and validated a complete process, from planning to implementation:
The whole process begins with the creation of a concept, which is the result of a teamwork between the various company departments and the collaboration with both our consolidated partners and the new ones.
The approved concept moves on to the next stage of the process: scientific validity. This can be implemented thanks to in-depth analyzes and close collaborations with the Key Opinion Leaders of the sector.
The results obtained in the previous phase are evaluated, then they continue with a search for raw materials and suppliers and finally they conclude with a search of the project validation center and a preliminary cost analysis.
If the project passes the evaluation and approval of our sales department or the client, this will be transferred to the production phase, within our production site: from laboratory to packaging.
BECOMING A MANUFACTURER HAS BEEN A VERY CHALLENGING MOMENT FOR US: WE ARE CONTINUOUSLY LOOKING FOR TECHNOLOGIES THAT ALLOW US TO IMPLEMENT OUR PRODUCTION CAPACITY.
In 2019 we designed and installed a customized machinery that allowed us to exponentially accelerate the production of our rapid tests, reaching a production of two million pieces per month. We have great flexibility in response to peaks in demand, both internal and external, thanks to different production lines. Our devices are manufactured according to the high standards of the Quality Management System, ISO 13485:2016 equipped with CE Certification, issued by the German Notification Body MDC.
Production begins in our laboratory where we develop our immunochromatographic technologies, which represent the beating heart of our rapid tests. These then move on to packaging, both manual and automatic, which represents 55% of our facility’s total surface.
WE WORK WITH CUSTOMERS WORLDWIDE TO PROVIDE ACCESS TO QUICK RESULTS THROUGH ACCURATE, HIGH-QUALITY TESTS AND IVDs.
We do not only take care of launching our products, but we are equally committed to the realization of customized private label projects. We study and develop an ad hoc solution for our clients, we follow them during the entire registration process and we offer the means necessary to launch a new product.
We at first recognize the need to be competitive in the growing market, which is why we understand our customers’ goals and do our best to turn their needs into results.
The world of diagnostics is progressively developing towards the self-testing market, thanks to the increasing awareness of the population’s health and the need to quickly obtain accurate results.