LEF’s Regulatory Affairs Department has been a provider of services to both National and European pharmaceutical industry companies. Our partners, National and Multinational companies, look for services in the scope of the MA management  (submission of new applications, renewals and MA variations), keeping in view the fulfilment of regulatory requirements. Our goal is to proactively ensure the quality of their products, and thus the efficacy and safety. In a coherent integrated environment, pharmacovigilance activities are also offered, including QPPV services.

The Regulatory Affairs Department relies on the great advantage of being part of a CRO structure that offers a set of integrated services, namely Compounding Development (production pilot-unit); Analytical Development and Clinical Trials. On the whole we have the skills to provide value in the healthcare area, and more specifically, in the medicine field.