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.



Clinical/Medical Writing

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