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.

Contact Us

Contact us - Toll Free

t+1 866.401.8003

Send email Contact us

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

Related Areas of Expertise

Pharmacovigilance Back to top

Connect With Us

Simple Share Buttons