VETERINARY MEDICINAL PRODUCT

Veterinary medicinal products

  • Pharmaceuticals
  • Biotech
  • Innovated products
  • Novel therapies
  • MUMs (minor use -minor species)

OFFERED SERVICES

  • Regulatory & strategic advice
  • Product development & business development
  • Requirements assessment, budget planning & timelines
  • The regulatory road map, product assessment & legal status
  • Data audits, GAP analysis & regulatory compliance
  • Literature search
  • SME and MUM applications
  • Communication with regulatory authorities:
    1. An innovation Taskforce (ITF),
    2. Scientific Advice (SA),
    3. Pre-submission meetings,
    4. Consultation with national authorities
  • Expert reports
  • Preparation for agency meetings (ITF, SA, etc.) & briefing packages
  • Preparation & submission of marketing authorization dossiers
  • Assistance with a post-submission response to questions
  • Life cycle management (modification, variation)