Regulatory Consulting

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