 |
||
 |
|
|
The CTD summary documents that WebbWrites prepares include:
- Module 2.5-Clinical Overview
- Module 2.7.1-Summary of Biopharmaceutic Studies and Associated Analytical Methods
- Module 2.7.2-Summary of Clinical Pharmacology Studies
- Module 2.7.3-Summary of Clinical Efficacy
- Module 2.7.4-Summary of Clinical Safety
- Module 5-Integrated Summary of Effectiveness
- Module 5-Integrated Summary of Safety
WebbWrites has extensive experience in helping companies file New Drug Applications (NDAs) using Common Technical Document (CTD) or original NDA formats. In addition to writing the clinical/statistical reports for all trial phases, we provide dedicated, on-site writing support as the submission deadline approaches.