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 |
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