Regulatory Writing:

• Clinical study protocols (CSPs)
• Informed consent forms (ICFs)
• Clinical study reports (CSRs) (Phase I-IV)
• Patient safety narratives for CSRs
• Preclinical reports
• Investigator brochures (IBs)
• Investigational medicinal product dossiers (IMPDs)
• Investigational new drug applications (INDs) and annual reports
• FDAAA clinical trial disclosure summaries
• Paediatric investigational plans (PIPs)
• Briefing packages
• Common technical document (CTD) summaries and overviews
• Regulatory response documents
• EU risk management plans (RMPs) **New 2013 format**

Educational/promotional writing:

• Manuscripts
• Abstracts
• Publication alerts
• Slide sets
• Study summaries and abstracts

Services provided are not limited to those listed above.  If you have other needs please get in touch to discuss further.