Pharmacovigilance

Medical writing services

Ashfield Pharmacovigilance offers a wide range of medical writing services to support your pharmacovigilance operations. Our experienced staff is well-versed in preparing a variety of documents necessary for safety reporting, risk management and regulatory compliance.

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Medical writing services include:

  • Aggregate periodic safety reporting (PADER, PSUR/PBRER, ASR/DSUR)
  • Medical Information Requests
  • Standard Response Letter Development
  • Specific questions from HCPs
  • Signal Evaluation Reports
  • Health Hazard Evaluations
  • Causality Assessments
  • ICSR Narrative Development
  • Risk benefit assessments
  • Analysis of Similar Events (AOSE)
  • Integrated Summary of Safety Sections (ISS)
  • NDA annual report safety sections
  • Product expectedness lists
  • “Dear Doctor” letters
  • Patient information leaflets
  • Abstracts/posters and manuscript development

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