Expertise

  • Ex-Regulatory expert (PEI, Germany)
  • Strategic advice and hands-on operational support
  • Expert knowledge in EU and Global Drug Regulatory Affairs
  • Broad spectrum of therapeutic areas and indications (Hematology, Hemato-, Neuro-, Oncology, CV, GI, CNS, neurodegenerative, autoimmune, infectious, thyroid diseases)
  • Broad spectrum of active substances (Biologicals: Blood-derived products, Biotech, Biosimilars, ATMP; small molecules; in vivo diagnostics)