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Regulatory Services

Regulatory Services

CBS works with Biotech, Pharmaceutical, Medical Devices, Nutraceuticals, Cosmetology and all other Life Sciences companies on the following, full or functional services involved in the regulatory lifecycle management.

  • Regulatory Strategy Development
  • Regulatory Agency Interactions and Preparations
  • Chemistry, Manufacturing and Controls (CMC Strategy, Gap Analysis & Authoring)
  • Dossier Submissions Management (CTD, eCTD, NeeS and Conversions)
  • Regulatory/Technical Writing (Non-clinical & Clinical)
  • Labelling Management, Renewals, Variations
  • Post Approval – CMC and Life Cycle Management
  • EU MDR/IVDR Support
  • EU PMS – FSCA Reporting

Technology

  • Regulatory Intelligence
  • eCTD
  • RIMS
  • Labelling
  • Smart workflow & automation / Plug-and-play