
Ectd Manager Software
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Product Specifications
| Compliance | 21 CFR Part 11 |
| Features | Lifecycle Management, Submission Publishing, Quality Control, Time Reduction, Global Dossier, Easy to use, EMA Approved |
| Markets Supported | EU, US, CA |
| Operating System | Windows |
| Software Type | Management |
| Submission Types | eCTD, NeeS |
| Usage | Pharmaceutical submission lifecycle management, including agency, post-approval maintenance life cycle. |
| User Interface | GUI |
Product Overview
Key Features
1. Lifecycle Management: Entire Submission, Multiple User Access and Compilation, management and publishing business process including eCTD Templates
2. Publishing of
- Paper Submissions
- Electronic (eCTD, NeeS, Others) Submissions
- Reports
3. Submission Management, Submission View, Submission Review, Submission Validation (In-built EMA Approved Validator) and Submission Publishing for EU, US, CA, JP, CH, MCC and GCC Markets (NDA, ANDA, CTA, eCopy etc.)
4. Sophisticated Management of Hyperlinks and Bookmarks, PDF Rendition
5. Very Efficient Parent/Child Generation
Used in different use cases:
- ASMF
- Global Dossier Management
- Duplicate Products
6. Multiple Submissions with reduce time for Quality Control and Submission Compilation and Publishing
For a full list of features of EXTEDO eCTDmanager and a copy of Product Brochure, please contact.
Company Details
Business Type
Service Provider
Establishment
2014
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Seller Details
Ahmedabad, Gujarat
Head - Regulatory Affairs
Mr. Kalpesh Khodifad
Address
Plot No A-915, Siddhi Vinayak Towers, Behind Adani CNG Pump, Makarba, Ahmedabad, Gujarat, 380051, India
document management system in Ahmedabad
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