Medical writing services
The Medfiles medical writers combine PhD-level expertise with excellent communications skills to deliver high-quality documents in line with your specifications.
Our team will prepare and fully manage your writing project or work with your team to support ongoing projects. Our writers can step in at any point of the product development life-cycle and provide full development and submission support, as well as review or develop individual documents.
Our experienced writers assist with all regulatory documents including:
- Phase I-IV clinical trial protocols and amendments
- Clinical trial reports (Phases I-IV)
- Clinical investigational plans (CIPs), clinical performance study plans (CPSPs) and corresponding reports for medical devices
- Clinical study protocols and reports for health claim substatiating studies
- Clinical evaluation plans (CEPs) and reports (CERs) for medical devices
- Periodic safety update reports (PSURs) and development periodic update reports (DSURs)
- ICSR case narrative writing
- Clinical overviews and summaries
Medical and regulatory writing
1. CLINICAL PHASE
- Clinical investigation plans
- Clinical trial protocols
- Clinical evaluation plans
- Investigator’s brochures
- Investigational medicinal product dossiers – CMC part
2. REGULATORY PHASE
- Clinical and non-clinical summaries and overviews for regulatory purposes
- Clinical evaluation reports
- Biowaiver justifications
- Environmental risk assessments phase I (ERAS)
- Clinical and biological evaluations of medical devices
3. MAINTENANCE
- Periodic safety update reports (PSURs) and risk management plans (RMS)
- Manuscripts for abstracts and publication
- Technical file maintenance
When you need accurate and clear writing tailored to your requirements, Medfiles delivers. See also:
