Regulatory Affairs

Regulatory Affairs is a profession developed in response to the desire of governments to control the safety and effectiveness of products in areas including pharmaceuticals, veterinary medicines and medical devices.

Panacea can assist your company to keep track of the ever-changing legislation in Europe, more specifically, providing support on the following regulatory activities:

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 Product Report Message (XEVMPD) maintenance