Regulatory Consulting

http://austincardealerships.com/?p=24499 AbNovo’s own staff will provide high level strategic consulting and legal-regulatory interpretation. These services include:

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  • 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

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