REGULATORY AFFAIRS KNOW-HOW

  • Pharmaceuticals
  • Immunologicals
  • Biologicals

REGULATORY STRATEGIES

  • MUMS (Minor use-minor species) products
  • Innovative products

REGULATORY DOCUMENTATION & SUBMISSION PROCESS

  • Compliance check of labels and product material
  • Expert Reports
  • MUMS applications
  • Marketing authorisation dossiers – complete or in parts, full or abbreviated
  • Electronic and/ or paper based submissions
  • Back/Forth questions with agencies