CTD/eCTD TAMPLATES & SOPs
DocentPharma eCTD/CTD submissions templates and standard operating procedure (SOP) are huge tools to increase efficiency, productivity, and consistency. DocentPharma eCTD/CTD submissions Microsoft Word® templates are well-formatted and easy-to-use templates. DocentPharma eCTD/CTD templates provides blueprint for text, graphics, styles and formatting of submission.
DocentPharma eCTD/CTD Templates and SOPs
| Template/SOP | Description |
| DocentPharma eCTD Templates for US submission | |
| Module 1 | 19 Templates for ANDA Submission |
| Module 2 Introduction | 1 Template for ANDA Submission |
| Module 2 Quality | 5 Templates for ANDA Submission |
| Module 2 Clinical | 3 Templates for ANDA Submission |
| Module 3 Drug Substance | 21 Templates for ANDA Submission |
| Module 3 Drug Product | 24 Templates for ANDA Submission |
| Module 3 Appendices, Regional Information & Literature | 7 Templates for ANDA Submission |
| Module 5 Clinical Study | 3 Templates for ANDA Submission |
| DocentPharma CTD Templates for Health Canada submission | |
| Module 1 | 20 Templates for ANDS Submission |
| Module 2 | 5 Template for ANDS Submission |
| Module 3 Drug Substance | 29 Templates for ANDS Submission |
| Module 3 Drug Product | 35 Templates for ANDS Submission |
| Module 3 Appendices, Regional Information & Literature | 10 Templates for ANDS Submission |
| Module 5 Clinical Study | 1 Template for ANDS Submission |
| DocentPharma SOP Templates | |
eCTD operation related SOPs |
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QA Related SOPs |
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For DocentPharma template or information, please write email to us: - docent@docentpharma.com
