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 (Blood-derived products, Biologicals, Biotech, Biosimilars, ATMP, small molecules, in vivo diagnostics)