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DocMedics is specialised in scientific & medical writing, editing and translation for the pharmaceutical and medical device industry.

Writing

DocMedics is specialised in writing and compiling documents for submission to regulatory authorities for marketing authorization of medicinal products and medical devices, publication in peer-reviewed journals and white-papers.

Editing

DocMedics offers both editing and proofreading. After editing, overall readability is ensured. Also, advice is given on how to make your document stronger and more readable. DocMedics ensures that the grammar and mechanical structure is perfect.

Translation

DocMedics is active as a translator of a diversity of English and German medical documents, such as SmPC and patient leaflet, into the Dutch language. DocMedics provides comprehensive and flexible medical translation services.

Let me introduce myself

In 2010, I started as a freelance medical writer after working as a medical writer for a clinical research organisation and a biotech company for over 12 years. Besides writing regulatory documents for the clinical and regulatory departments, I have experience with medical communication documents for the marketing and medical affairs departments. In addition I am active as a translator of a diversity of German and English medical documents (e.g. SmPC and patient leaflet) into the Dutch language.
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Regulatory documents

All regulatory documents are based on the ICH/GCP guidelines or EudraVigilance templates.

• Clinical study protocols and amendments
• Investigator Brochures
• Clinical study reports: Phase I, Phases II-IV
• CTD: Summary of Clinical Safety; Summary of Clinical Efficacy; Clinical Overview
• Periodic Safety Update Reports
• Annual Safety Reports
• Risk Management Plans

 

Medical communication

The medical communication documents I have
written are listed below.

• Manuscripts
• Abstracts
• Posters
• Slide sets
• Proceedings of conferences
• Annotations
• Publication plans
• Product monographs