Regulatory Affairs

Pre-authorisation

  • Marketing authorisation applications and
    submissions

 

  • Product information
    • Creation of SmPC’s , PIL’s and labelling
    • Creation of mock-ups
    • Braille verification
    • Readability user testing
    • Creation of risk management plans

Post-authorisation maintenance

  • Variations
  • Marketing authorisation renewals
  • Marketing authorisation extensions
  • Sunset clause submissions
  • Marketing authorisation transfers
  • Marketing authorisation withdrawals
  • Creation and submission of PSUR’s
  • Maintenance of product information
  • Extended Eudravigilance Medicinal Product Dictionary
    (XEVMPD) maintenance

or call +44 1624 672777