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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