Regulatory Writing
IND/NDA summaries, clinical study reports and regulatory correspondence.
3 Prompts
PROMPT 01
Clinical Study Report Executive Summary
Write an executive summary for a Clinical Study Report (CSR) for [study title/protocol number]. Include: study objective, design overview (phase, population, endpoints), key efficacy results (primary and secondary endpoints with statistical results), safety summary (AEs, SAEs, discontinuations), and overall conclusion. ICH E3 compliant. Approx. 600 words.
CSR
Regulatory Writing
PROMPT 02
Regulatory Agency Correspondence
Draft a response letter to [FDA/EMA/MHRA/TGA] regarding their query on [submission number/product]: [describe query]. Include: acknowledgement of query, response to each question (numbered to match agency's questions), supporting data summary, and commitments or next steps. Tone: professional, precise, collaborative with the regulator.
Regulatory Correspondence
Agency Response
PROMPT 03
Benefit-Risk Summary
Write a benefit-risk summary for [drug name] ([indication]) for inclusion in a regulatory submission. Structure: summary of established benefits (with trial evidence), summary of known risks (safety profile by system organ class), benefit-risk assessment (context of disease, treatment alternatives, patient population), and conclusion on overall benefit-risk balance.
Benefit-Risk
Regulatory
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