Medfiles Global medical writers combine PhD-level expertise with excellent communications skills to deliver high-quality documents to your specifications. Our team will fully prepare and manage your writing project or work with your team to provide support for an ongoing project. Medfiles‘ medical writing team can step in at any point in your product development life cycle to provide full development and submission support, as well as review or develop individual documents.
Our experienced writers assist with all associated regulatory documents including:
- Phase I-IV clinical study protocols and amendments
- Clinical study reports (Phases I-IV)
- Investigational plans for medical device studies
- Clinical study prtocols and report for health claim substatiating studies
- Clinical evaluation reports (CERs) for medical devices
- Periodic safety update reports (PSUR)
- Data and safety monitoring board (DSMB) reports
- SAE reports for submission to all required authorities (e.g., FDA, IRB, CA/EC)
When you need accurate and clear writing tailored to fit your requirements, Medfiles Global delivers.