At KONEXIO BIOTECH, our regulatory affairs service provides comprehensive and strategic support in the regulatory field, starting with the creation of personalized roadmaps to guide our clients towards the quick and efficient approval of their products. We conduct a thorough review of the integrity and accuracy of regulatory documents, ensuring they meet all necessary requirements. Additionally, we prepare and submit complete regulatory dossiers to the corresponding entities, managing the entire process from creation to approval. We conduct regulatory audits to ensure that all registration dossiers are in perfect order, minimizing risks and optimizing timelines.

For medicines, we develop detailed strategies to obtain approval more quickly, supervising and auditing the dossiers to maintain rigorous control over the project. We offer scientific consultations with regulatory agencies and manage all necessary modules: from Module 1, which includes aspects such as ERA, PV system, and RMP, to Modules 3, 4, and 5, which cover quality, non-clinical, and clinical, respectively. Our highly trained team, composed of professionals with academic training and field experience (MD, PhD), ensures expert handling of each phase of the process.

In the field of medical devices, we handle the creation of risk management plans, obtaining necessary licenses for manufacturers, importers, sterilizers, or assemblers, and the regulatory qualification and classification of the products. We prepare technical dossiers in compliance with MDR and IVDR regulations and coordinate with notified bodies for obtaining CE marking. For cosmetics, we manage the application for certificates, the responsible declaration of manufacturing or import activities, and the preparation of the information dossier and notification to the European portal. In the area of nutraceuticals, we assist in the registration of the responsible company in the RGSEAA, the communication of products to the market, and the management of modifications and cessation of activities, ensuring that all new foods comply with current regulations.