Novella Clinical’s Regulatory Affairs department provides comprehensive international support for all sizes of medical device, diagnostic and combination product companies. Offering both operational and strategic consulting services, our team is experienced in working with regulatory agencies as well as IRB/ethics committees.

Our regulatory and reimbursement experts include former sponsor and industry trained professionals who provide proven guidance to sponsors as they navigate the nuances of preclinical submissions, determinations and evidence generation strategies. We work with our customers to develop smart and efficient regulatory strategies followed by effective regulatory submissions.

Our Regulatory Affairs services include:

 

  • Development strategies and overall development plans
  • Clinical Development planning and cost analysis
  • Protocol or Clinical Investigational Plan (CIP) development
  • Regulatory assessments (US, Europe and Asia)
  • Class II 510(k) meeting request and submission dossiers
  • Pre-IDE meeting preparation and meeting leadership
  • IDE regulatory support and submissions
  • Class III PMA Support (Medical/Clinical)
  • Reimbursement strategies
  • Report of prior investigations
  • Agency audit support and warning letter resolution
  • SOP development
  • Device classification/predicate device searches
  • Import/export requirements and management
  • Creation of technical design files
  • Clinical evaluation reports
  • BIMO inspection support
  • Post-market support