OUR EXPERTISE

The AR2i REGULATORY AFFAIRS Division is here to help you with your regulatory applications in extensive range of subjects.
We have a solid expertise in preparing CMC dossiers and experience in working on a wide variety of active susbtances and pharmaceutical forms.

  • TECHNICAL-REGULATORY ADVICE

    • Regulatory intelligence
    • Registration strategy
  • Contact/meetings with the authorities

  • COORDINATION OF PHARMACEUTICAL STUDIES:
  • Analytic and pharmaceutical studies, Site Transfer

    • Regulatory advice
    • Study implementation
  • Follow-up and analysis of data

  • AUDIT

    • Regulatory portfolio
    • Module 3
    • Gap analysis
  • Action plan proposals
  • Risk analysis

  • DRAFTING OF MARKETING AUTHORIZATION APPLICATION DOSSIERS

    • Module 3
    • Full applications
    • Variation applications
  • Responses to questions from the authorities
  • Quality Overall Summary
  • Baselines eCTDs

  • PRODUCT INFORMATION : SmPC, Leaflet and Labelling

    • Product information variation dossiers
    • Template formatting
    • Comparison and alignment
  • Checking of press proof document
  • User testing of leaflets

  • SUBMISSION OF REGULATORY APPLICATIONS TO THE AUTHORITIES

    • e-CTD submission (EnnoV software)
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