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Medical Writing ԰ for Regulatory and Clinical Research

Experience Matters. Trust ԰to Get It Right.

1200+

Clinical Evaluation Reports Prepared

12

Full Time Medical Writers on Staff

90%

Medical Writers with Advanced Degrees

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

԰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.

Take the Next Step

Want to learn more about our medical writing experience in support of clinical trials or regulatory compliance? Wondering how long it will take, how we approach it, and how much it will cost?

Schedule a Consultation

Meet Our Medical Writing Team

Explore the depth of our team’s qualifications and experience.

See All Medical Writers
  • Áine Mary Duffy, BSc (Hons), PhD

    Clinical & Regulatory Operations Manager
    View Bio
  • Sean Bird, PhD

    Principal Medical Writer
    View Bio
  • Caroline Guidicelli, MSc, MEng

    Caroline Guidicelli
    Principal Medical Writer
    View Bio
  • Séverine Oudin-Fantin, PhD

    Manager–EMEA Medical Writing ԰
    View Bio
  • Aurélie San Juan, MSc, PhD

    Principal Medical Writer, Regulatory
    View Bio

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