Medical / Regulatory Writing Services
Medical / Regulatory Writing Services
FiunEx Medical / Regulatory Writing Services, your gateway to precision and clarity in clinical trial documentation. We specialize in delivering comprehensive writing solutions that ensure your clinical trial documents are not just accurate but submission ready. With FiunEx, your clinical trial success is underpinned by unwavering clarity and precision. Our team of expert medical writers comprises PhD-level scientists with excellent written communication skills. They have a diverse range of medical writing experience, as well as knowledge of regulatory documents over a wide spectrum of therapeutic areas.
Services
Clinical/Medical Writing
(MDR&IVDR)
Ad-Hoc Medical Writing Support
Clinical evaluation plans and clinical evaluation report (CEP, CER)
Clinical investigation plans and reports (CIP, CIR)
Performance evaluation plans and performance evaluation reports (PEP, PER)
Scientific validity reports (SVR)
Analytic performance reports (APR)
Clinical performance reports (CPR)
Literature search reports
Summary of Safety and Clinical Performance document (SSCP)
Regulatory Writing
Medical marketing, education, and publications
Clinical Study Reports (CSRs)
Conference Abstracts
Instruction for Use (IFU), User Guide and Labelling (Creation or Editing)
Investigator Brochures
Journal Articles: Preclinical and Clinical Study Manuscripts for Submission to Peer-Reviewed Journals
Labelling, Instructions for Use (IFUs) and User Manuals
Systematic Literature Reviews and Associated Meta-Analysis