Regulatory Affairs

Preliminary consultancy, project definition and management.

SPECIFIC CONSULTATIONS AND PRODUCTS

  • Site Master File.
  • AIFA notification.
  • DMF preparation (e-CTD format) Europe, Canada and USA.
  • CEP (Certificate of suitability) preparation and submission support.
  • Suitability dossier.
  • Plans and report for process validation, cleaning and analytical.
  • Stability protocols.
  • SOPs (Standard Operating Procedure).
  • Specific Risk Assessment.
  • Pre-audit GMP and inspection to non-EU manufacturer’s sites.
  • Training.
  • Temporary Manager for assistance to QP and QA managers.