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Services

Medical writing services that I offer include the following. This is not an exhaustive list so please contact me to discuss how I can help with your project. I also offer quality control review of documents.

Regulatory and Clinical Writing

  • Briefing documents (e.g. for EMA/FDA scientific advice)

  • Clinical evaluation reports for medical devices

  • Clinical summaries and overviews

  • Continuing (medical) education materials

  • Clinical study reports (Phases I-IV)

  • Paediatric investigation plans

  • Protocols and amendments

  • PSURs/PBRERs

  • Regulatory responses to questions, and other post-submission support

  • Risk management plans

Medical Communications / Other

  • Abstracts

  • Manuscripts

  • Meeting reports

  • News articles

  • Product monographs

  • Patient and consumer health education

  • Slide sets

  • Training manuals

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