Expertise

• Ex-Regulatory expert (PEI, Germany)
• Strategic advice and hands-on operational support
• Expert knowledge in EU/global Regulatory Affairs (all development phases)
• Broad spectrum of therapeutic areas and indications (Hematology, Oncology, CV, CNS, neurodegenerative diseases, GI, Infectious diseases)
• Broad spectrum of active substances (Biologicals: Blood-derived products, Biotech, Biosimilars, ATMP; small molecules; in vivo diagnostics)