PV writing


Our PV writing team comprises of healthcare professionals, physicians, scientists and regulatory experts who are well trained with extensive experience across all therapeutic areas to understand the global regulatory requirements.

Mediscribe specialists are well versed in preparing the documents listed below in the requisite format with the appropriate clinical content that can be submitted to the relevant regulatory authorities within the compliant timeline.

  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit Risk Evaluation Reports (PBRERs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)
  • IND Annual Safety Reports (ASRs)
  • Summary Bridging Reports (SBRs)
  • Safety summary updates
  • Addendum Reports
  • Support for Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy (REMS)