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)
– Enforcement by Competent Authorities
– Crisis management
– Medical device classification and legal borderline determination (especially between medicinal products (drugs) and medical devices)
– Litigation support