Description

Regulatory Submission

100 Prompts to help draft sections of New Drug Applications (NDAs) or Investigational New Drug (IND) applications, ensuring they meet specific regulatory frameworks.

Prompt ID	Prompt Text	Difficulty Level	Target User	Use-Case Tags
MODULE 1: ADMINISTRATIVE & PRESCRIBING INFORMATION (1-15)
REG-ADM-001	Draft the Comprehensive Table of Contents for a New Drug Application (NDA) following the eCTD structure.	Beginner	Regulatory Operations	#eCTD #ToC #NDA_Structure
REG-ADM-002	Generate the completed FDA Form 356h (Application to Market a New Drug) for an NDA submission.	Intermediate	Regulatory Affairs Specialist	#FDA_Form_356h #Application_Form
REG-ADM-003	Draft the Cover Letter for an original NDA submission to the FDA.	Beginner	Regulatory Affairs Specialist	#Cover_Letter #NDA_Submission
REG-A DM-004	Create the proposed Prescribing Information (USPI) / Summary of Product Characteristics (SmPC) for [Drug Name].	Advanced	Regulatory Labeling Lead	#USPI #SmPC #Labeling

MODULE 2: SUMMARIES (16-35)
REG-SUM-016	Draft the overall Comprehensive Summary for Module 2, providing a high-level synthesis of the quality, nonclinical, and clinical data.	Advanced	Regulatory Strategy Lead	#Comprehensive_Summary #Module_2
REG-SUM-017	Generate the Quality Overall Summary (QOS) for the drug substance.	Advanced	CMC Expert	#QOS #Drug_Substance #Module_2
REG-SUM-018	Generate the Quality Overall Summary (QOS) for the drug product.	Advanced	CMC Expert	#QOS #Drug_Product #Module_2
REG-SUM-019	Draft the Nonclinical Overview, providing a critical assessment of the pharmacology, PK, and toxicology studies.	Advanced	Nonclinical Strategist	#Nonclinical_Overview #Module_2

MODULE 3: QUALITY (CMC) – DRUG SUBSTANCE & PRODUCT (36-55)
REG-CMC-036	Draft the Body of Data for the Drug Substance (Module 3.2.S), describing the manufacture, characterization, and control of the API.	Advanced	CMC Expert (API)	#Drug_Substance #Module_3
REG-CMC-037	Generate the Description and Composition of the Drug Product (Module 3.2.P.1).	Intermediate	CMC Expert (DP)	#Drug_Product_Composition #Formulation
REG-CMC-038	Draft the Pharmaceutical Development report (Module 3.2.P.2).	Advanced	Formulation Scientist	#Pharmaceutical_Development

MODULE 4: NONCLINICAL REPORTS (56-70)
REG-NC-056	Draft the detailed study report for the Primary Pharmacology studies.	Advanced	Pharmacologist	#Primary_Pharmacology #MOA
REG-NC-057	Generate the detailed study report for the Safety Pharmacology studies (cardiovascular, CNS, respiratory), following ICH S7A and S7B.	Advanced	Safety Pharmacologist	#Safety_Pharmacology #ICH_S7
REG-NC-058	Draft the detailed study report for the Pharmacokinetics studies (ADME) in animals.	Advanced	DMPK Scientist	#ADME #Pharmacokinetics

MODULE 5: CLINICAL STUDY REPORTS & DATA (71-100)
REG-CLIN-071	Draft the full Clinical Study Report (CSR) for the pivotal Phase 3 trial [Trial Acronym], following the ICH E3 guideline structure.	Advanced	Medical Writer	#CSR #ICH_E3 #Phase_3
REG-CLIN-072	Generate the Protocol and Protocol Amendments for the main efficacy study.	Intermediate	Clinical Scientist	#Study_Protocol #Amendment
REG-CLIN-073	Draft the Sample Informed Consent Form (ICF) and any updates used in the pivotal clinical trials.	Intermediate	Clinical Operations	#Informed_Consent #ICF
REG-CLIN-074	Generate the List of Investigators and List of Laboratories (and 1572 forms for US).	Beginner	Regulatory Submission Manager	#Investigator_List #Form_1572
REG-CLIN-075	Draft the Integrated Summary of Efficacy (ISE).	Advanced	Biostatistician	#Integrated_Summary_Efficacy #ISE