sfp consulting, LLC

Writing Services


Clinical trial-related documents

Clinical Study Protocols
Integrated Clinical/Statistical Reports (Phases 1-4)
Patient Narratives
Manuscripts
Abstracts and Posters
Project-related Newsletters
Informed Consent Forms



Regulatory Documents

CTD Summaries of Clinical Safety and Integrated Summaries of Safety (ISS)
CTD Summaries of Efficacy and Integrated Summaries of Efficacy (ISE)
CTD Clinical Overview (including Benefit/Risk summary)
Other CTD components (eg, prescribing information and patient information leaflet)
NDA 120-day Safety Updates
Investigational New Drug Applications
Investigational New Drug Annual Reports
Investigational Drug Brochures
FDA Meeting Packages






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