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 commercialization 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