Regulatory Services

CNE can work with you to help develop the most time and cost effective nonclinical and clinical regulatory strategies possible. By having extensive experience working in the regulatory environment we can troubleshoot and/or prevent problematic nonclinical and clinical regulatory issues. CNE can author nonclinical or clinical sections for regulatory submissions, whether approval is being sought in the US or Europe. We can be part of your team to represent your company for telecommunication or face-to-face meetings with the regulatory bodies. When needed, CNE can author rebuttals to regulatory responses where nonclinical and clinical issues have been identified.

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  • Regulatory interactions in the major marketing territories
  • Clinical and nonclinical regulatory strategy development and execution
  • Development of risk management startegy for nonclinical issues arising from CTD preparation
  • Writing and/or review of nonclinical regulatory documentation
    • CTD, IND, NDA, IB
  • Expert reports and Independent safety assessments
  • Writing and review of clinical sections of regulatory dossiers
    • IND, NDA, MAA, CTAs, SmPCs
  • Expert Reports and Orphan Drug
  • Designation Dossiers
  • Review, analysis and preparation of responses to regulatory questions
  • Expert representation at EU Competent Authority and US FDA meetings
  • Due diligence reviews of nonclinical and clinical regulatory documentation
  • Medical expertise for design review and approval of medical marketing materials