Stela Costa Comparini

Regulatory Affairs expertise including the following activities: Management of new registrations and variations of biological products, synthetic drugs and medical devices. Maintenance of sanitary licenses. Management of Clinical Trial applications (ANVISA) submission and maintenance. Regulatory Intelligence. People and budget Management. Meetings with local Health Authorities and ANVISA. Regulatory support to new product launches in multidisciplinary teams. National and international GMP inspections - ANVISA. Working groups and meetings at pharma association. (Source: Lattes Curriculum)