Medical Writing and Publication Assistance

MC-RWE >Publication Assistance

Medical Writing and Publication Assistance


Medical/Scientific writing involves preparing scientific documentation, which complies with regulatory, journal, and other guidelines in terms of content, format and structure. With our team of expert medico-scientific writers, we offer:

  • Protocol and informed consent documents
  • Investigator brochures
  • Patient safety narratives and clinical study reports (CSRs)
  • Clinical summary and clinical overview documents for e-CTD (electronic common technical document) submissions
  • Non-clinical summary and non-clinical overview documents for e-CTD submissions
  • New drug application (NDA) and investigative new drug application (INDA)
  • Development safety update reports (DSUR) and periodic safety update reports (PSUR)

HIGHLIGHTS

Some of the Key highlights of our offering include- preparing scientific documentation, which comply with regulatory, journal, or other guidelines in terms of content, format and structure.

  • MC has an exceptional collection of experts across multiple therapeutic areas, including respiratory medicine, oncology, neurology, dermatology, and rheumatology.
  • Our team of scientific writers who have deep writing experience in various peer-reviewed journals offer flexible solutions from single documents to an entire publication support.
  • Our document publishing team has expertise in several software applications used for electronic publishing, providing full or submission-ready publishing services.
  • Writers have diverse academic and professional backgrounds along with strong analytical, communications, and project management expertise.
  • We can readily adapt documents to meet your preferred styles and formats and are supported by document specialists who are seasoned quality control pros.