Regulatory Affairs

In an area as important as regulatory affairs, you need expertise to avoid costly mistakes and to reduce delays.

We can provide:

  • Regulatory Assessments; Class determination and details on the most efficient pathway to product clearance
  • Risk Assessments/Hazard Analyses
  • Clinical study design, protocols, data analysis and reports
  • Design verification and validation reports
  • Product Labeling
  • Marketing/Technical Support information
  • Writing and support of all types of regulatory submissions
    • 513(g) – Class determination
    • RFD – Request for Designation of Combination Products
    • Q-subs – Presubmissions5
    • 510(k) and De Novo – Premarket Notification
    • MAF – Device Master Files
    • PMA – Pre-Market Approval
    • IDE – Investigational Device Exemptions (for clinical trial leading to PMA)
    • HDE – Humanitarian Device Exemption
    • BLA – Biologics License Application
    • CMC Sections – Chemistry, Manufacturing, Controls sections for IDE and PMA
    • Clinical Evaluation Reports, Technical Files, Design Dossiers for Notified Bodies