Client lacking resources for EU publishing activities

  • Global generic company needed support for EU publishing activities for parts of its product portfolio.
  • All EU eSubmission activities (eCTD, NeeS) were transferred to PharmaLex.
  • Scope of PharmaLex responsibilities:
    • Direct correspondence and interactions with Regulatory Affairs functions.
    • Collection of related documentation.
    • All dossier as well as submission activities.