Scientific Writing

Katalyst’s highly experienced and broad knowledge team of medical writers work on a variety of projects from initial protocol development to clinical study reports and final regulatory documentation. Our medical writers will ensure clear written and high quality communications with sites, investigators and concerned regulatory agencies throughout the product development and commercial process.

Katalyst’s Medical/Scientific Writing Services:

Clinical Documents

  • Clinical Study Protocols & SOPs
  • Case Report Forms (CRFs)
  • Investigator Brochures
  • Interim & Final Clinical Study Reports (Phase I-IV)
  • Consent forms/Patient information
  • Clinical Safety narratives/summaries
  • Integrated Summaries of Safety and Efficacy (ISS & ISE)

Regulatory Documents

  • INDs, IDEs, NDAs, BLAs, ANDAs, MAAs, PMAs, DMFs and other international drug submissions
  • Orphan drug application support
  • Drug and Drug Product Annual Reports
  • Responses and briefing documents for regulatory agencies
  • Clinical Sections of the Common Technical Document (CTD/eCTD)
  • Risk Management Plans (RMP)

Pharmacovigilance Documents

  • Adverse Events (AEs) & Serious Adverse Events (SAEs) Narratives
  • Periodic Safety Update Reports (PSURs)
  • Annual Safety Reports

Other Scientific Communications:

  • Abstracts, Manuscript, Posters, Brochures and Slides
  • Regulatory guidance and review of advertising/promotional/marketing materials
  • Literature Reviews
  • Editorial Support
  • Journal and Conference Submissions
  • Medical educational and training materials