Ectd Manager Software
1. Lifecycle Management: Entire Submission, Multiple User Access ...View Product Details
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
Focusing on a customer-centric approach, Prelude Regulatory Services has a pan-India presence and caters to a huge consumer base throughout the country. Get Software from Prelude Regulatory Services at Trade India quality-assured services.
Business Type
Service Provider
Establishment
2014
Seller Details
Prelude Regulatory Services
Head - Regulatory Affairs
Mr. Kalpesh Khodifad
Address
Plot No A-915, Siddhi Vinayak Towers, Behind Adani CNG Pump, Makarba, Ahmedabad, Gujarat, 380051, India
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