Documents and Templates
Access over 400 eCTD-compliant templates for INDs, NDAs, and BLAs with guidances, descriptions, and unified styling and learn more about the information Artos uses in its AI.
Don't see the template you're looking for? Email info@artosai.com. More templates are also regularly released here, so feel free to check back.
CTD Module 1
Admin Module
CTD Module 1
Admin Module
CTD Module 1
Admin Module
1.6.1 Meeting Request
1.6.1 Meeting Request
1.6.1 Meeting Request
1.6.1 Meeting Request Biosim…
1.6.1 Meeting Request Biosim…
1.6.1 Meeting Request Biosim…
1.6.2 Pre-IND Meeting Back…
1.6.2 Pre-IND Meeting Back…
1.6.2 Pre-IND Meeting Back…
1.6.2 Pre-NDA Meeting Back…
1.6.2 Pre-NDA Meeting Back…
1.6.2 Pre-NDA Meeting Back…
1.7.1 Fast Track Designation…
1.7.1 Fast Track Designation…
1.7.1 Fast Track Designation…
1.8 Special Protocol Assess…
1.8 Special Protocol Assess…
1.8 Special Protocol Assess…
1.12.17 Orphan Drug Design…
1.12.17 Orphan Drug Design…
1.12.17 Orphan Drug Design…
1.20 General Investigati…
1.20 General Investigati…
1.20 General Investigati…
Breakthrough Therapy Desig…
Breakthrough Therapy Desig…
Breakthrough Therapy Desig…
1.14.4.1 Investigator's Brochu…
1.14.4.1 Investigator's Brochu…
1.14.4.1 Investigator's Brochu…
CTD Module 2
Summary Module
CTD Module 2
Summary Module
CTD Module 2
Summary Module
2.2 Introduction to Summary
2.2 Introduction to Summary
2.2 Introduction to Summary
2.3 Intro to QOS
2.3 Intro to QOS
2.3 Intro to QOS
2.3.A Documents
2.3.A Documents
2.3.A Documents
2.3.P Documents
2.3.P Documents
2.3.P Documents
2.3.R Regional Information
2.3.R Regional Information
2.3.R Regional Information
2.3.S Documents
2.3.S Documents
2.3.S Documents
2.4 Nonclinical Overview
2.4 Nonclinical Overview
2.4 Nonclinical Overview
2.5 Clinical Overview
2.5 Clinical Overview
2.5 Clinical Overview
2.6.1 Introduction
2.6.1 Introduction
2.6.1 Introduction
2.6.2 Pharm Written Summ…
2.6.2 Pharm Written Summ…
2.6.2 Pharm Written Summ…
2.6.4 PK Written Summary
2.6.4 PK Written Summary
2.6.4 PK Written Summary
2.6.6 Toxicology Written Su…
2.6.6 Toxicology Written Su…
2.6.6 Toxicology Written Su…
2.6.3/5/7 Tabulated Summar…
2.6.3/5/7 Tabulated Summar…
2.6.3/5/7 Tabulated Summar…
2.7.1 Summary of Biopharma…
2.7.1 Summary of Biopharma…
2.7.1 Summary of Biopharma…
2.7.2 Summary of Clinical Ph…
2.7.2 Summary of Clinical Ph…
2.7.2 Summary of Clinical Ph…
2.7.3 Summary of Clinical Ef…
2.7.3 Summary of Clinical Ef…
2.7.3 Summary of Clinical Ef…
2.7.4 Summary of Clinical Sa…
2.7.4 Summary of Clinical Sa…
2.7.4 Summary of Clinical Sa…
2.7.5 References
2.7.5 References
2.7.5 References
2.7.6 Synopses of Individua…
2.7.6 Synopses of Individua…
2.7.6 Synopses of Individua…
CTD Module 3-5
Please email info@artosai.com for templates!
CTD Module 3-5
Please email info@artosai.com for templates!
CTD Module 3-5
Please email info@artosai.com for templates!
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