At KONEXIO BIOTECH, we offer specialized preclinical services that cover the regulatory classification of various types of products, including ATMPs, biological drugs, products regulated by MDR and IVDR, cosmetics, and novel foods. Our expert team designs customized preclinical experimental plans for both drugs and biological products, ensuring that each step complies with specific regulations. We also specialize in designing preclinical experimental plans for medical devices, aligning with IVDR and MDR requirements to ensure that preclinical studies provide robust and reliable data.

Additionally, at KONEXIO BIOTECH, we provide scientific consultations with regulatory agencies such as EMA, FDA, ENVISA, and AEMPS, facilitating communication and compliance with international regulatory standards. Our service includes a detailed biostatistical analysis of the results, ensuring that the obtained data are accurately interpreted and effectively used in product development. Furthermore, we manage and coordinate preclinical projects comprehensively, overseeing each phase to ensure that objectives are met on time and within budget, optimizing resources and ensuring the success of preclinical studies.