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Medical & Regulatory Writing

Premier Consulting provides medical writing and editing services for a wide variety of regulatory documents, ranging from pre-IND submissions through post-marketing commitments. We have extensive experience supporting both single-document and large-scale submissions across a diverse assortment of indications. Our writers are familiar with regional healthcare authority requirements, ICH and GCP guidelines, and best industry practices, and our documents are prepared in eCTD format.

Premier Consulting’s regulatory medical writing services include:

Regulatory Document Services

Clinical Document Services

  • Protocols
  • Protocol amendments
  • Clinical study reports
  • Annual reports
  • Narratives
  • Executive summaries

Meet Our Experts

Kristen Drake

Director, Medical Writing

Scott Slough

Principal Medical Writer (II)

Michelle Coughlin

Manager, Medical and Regulatory Writing

To partner with Premier Consulting on your medical writing, Contact Us.