ASKLEP will prepare periodic safety update reports and reexamination dossiers in compliance with the relevant regulations and guidelines.

Service line-up

  • Support preparation of data for periodic safety update reporting
  • Support preparation of documentation for reexamination submission
  • Translate various reports and application documents into English and perform quality checks

Our Advantages

  • Our resources with expertise can help you prepare updated draft reports.
  • Prior to drafting reports, we sit down with the client to go over content needed for final reports and other documentation.
  • Records of preparation are documented at each step in compliance with ISO9001.