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:
- An innovation Taskforce (ITF),
- Scientific Advice (SA),
- Pre-submission meetings,
- 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)