Navigating in Woods

Regulatory Affairs

Turn your regulatory strategy into a competitive advantage with a well thought-out plan and expert execution.

Regulatory Strategy

  • Initial Product Assessment

  • Product Regulatory Pathway, including classification, strategy and plan






     

Regulatory Submissions

  • Letter to File (LTF)

  • 510(k)

  • De Novo

  • Premarket Approval (PMA)

  • Investigational Device Exemption (IDE)

  • Pre-Submission

  • Certificate to Foreign Government (CFG)

  • EU & OUS Technical File Support

Regulatory Support

  • Warning Letter Support

  • Labeling Support

  • Marketing Material Support

  • Inspection Preparations

  • Regulatory Agency Communications & Interactions

  • Recall & Field Correction Action Support