Regulatory services:

  • Advice and strategy for European, Canada and FDA submission procedures.
  • Lifecycle development planning.
  • Regulatory gap analysis & due diligence.
  • Scientific advice, expert oversight and review of data.
  • Follow-up strategies and action.
  • CTD preparation of modules, overviews and summaries- electronic submissions prepared in the eCTD, NeeS, VNeeS and other electronic dossier formats.
  • ASMF preparations for centralised, decentralized, mutual Recognition and national procedures.
  • Annual updates and amendments for US, Europe (CEP & ASMF), WHO and Canada.

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For more information email us at info@pharexcelconsulting.com or contact us today.