Inspection Preparation and Remediation

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  • Iolite has an excellent track record in assisting companies to obtain or retain Manufacturing, Wholesaler's or "Specials" Authorisations
  • Preparation for and management of regulatory inspections conducted by the following agencies:
    • FDA - US
    • TGA - Australia
    • EMA - Europe
    • MHRA - UK
    • HPRA - Ireland
    • Other EU Competent Authorities
    • MHLW - Japan
    • ISO 9001 - UK Certifying Bodies
    • ISO 13485 - UK Certifying Bodies
  • Regulatory inspection preparation and follow up
  • Remediation of adverse inspection findings
    • Redesign of pharmaceutical quality system, Risk Assessment, Submissions to Regulatory agency, requests for information
  • Advice on inspection procedure and management
  • Submission to regulatory agencies and responses to requests for information