Medical Writing Services for Regulatory and Clinical Research

A Medical Writing Team 100% Focused on Medical Devices and IVDs

NAMSA provides a wide range of specialized clinical and regulatory medical writing, manuscript submission and evidence communication services. Our world-class team of medical writers is expert at identifying, organizing, interpreting and presenting clinical data accurately and professionally for submission to various regulatory bodies.

NAMSA’s medical writing services team is also experienced and skilled in developing Clinical Evaluation Plans and Reports to comply with the Medical Device Regulation (MDR), as well as Performance Evaluation Plans and Reports to comply with the In Vitro Diagnostic Regulation (IVDR). Working in collaboration with our US and EU regulatory teams, we have extensive experience preparing:

• Clinical Evaluation Reports and Plans (CER and CEP)
• Performance Evaluation Reports and Plans (PER and PEP)
• Clinical Literature Reviews
• Periodic Safety Update Reports (PSUR)
• Post Market Surveillance Reports (PMSR)
• Summaries of Safety and Clinical Performance (SSCP)
• Clinical Study Protocols
• Clinical Study Reports (CSR)

NAMSA’s global regulatory and clinical medical writing team is comprised of dedicated professionals from a diverse range of clinical and scientific backgrounds, 90% of whom hold advanced degrees.

Working in close partnership with NAMSA’s regulatory, clinical and biostatistics teams, our medical writers are highly responsive to individual needs and are instrumental in helping clients achieve commercial objectives. When working with NAMSA, clients are also provided with a personalized plan to help guide future compliance activities.