AbNovo’s own staff will provide high level strategic consulting and legal-regulatory interpretation. These services include:
- General regulatory strategy and advice (all compliance issues)
- Due diligence audits
- Briefing on current regulatory trends
- Legal and regulatory interpretation (including European and national requirements within the European Union as well as the United Kingdom)
- Post-market surveillance (including vigilance)
- Enforcement by Competent Authorities
- Crisis management
- Medical device classification and legal borderline determination (especially between medicinal products (drugs) and medical devices)
- Litigation support
- Compliance issues related to Artificial Intelligence