Regulatory COA Strategy Consulting & Support
We can help you to develop a comprehensive COA strategy for your clinical program, from start to finish:
COA instrument selection & endpoint definition
• COA gap analysis
• COA landscape assessment & literature reviews
• Regulatory submission support (advise, briefing documents, meetings)
Specifically, we have extensive experience with and offer support for:
Identifying COA instruments and defining study endpoints.
Conducting Landscape Assessments or Gap Analyses to identify key disease concepts, instruments, gaps in validation evidence, and understand your competitor landscape (including label claims).
Analysing available clinical data to test hypotheses and identify key trends/patterns in your data that can help inform or support the COA strategy .
We can collaborate with you to support submissions to the FDA and EMA.
We have extensive experience liaising with FDA and EMA, and specialize in supporting the development of regulatory documents (e.g., briefing packages, responses to feedback) and attendance of key meetings to present/defend COA evidence.
Have a chat with us
Got any questions? Contact us and we'll be happy to help.