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