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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