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Ectd Manager Software

Ectd Manager Software

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Product Specifications

Compliance21 CFR Part 11
FeaturesLifecycle Management, Submission Publishing, Quality Control, Time Reduction, Global Dossier, Easy to use, EMA Approved
Markets SupportedEU, US, CA
Operating SystemWindows
Software TypeManagement
Submission TypeseCTD, NeeS
UsagePharmaceutical submission lifecycle management, including agency, post-approval maintenance life cycle.
User InterfaceGUI

Product Overview

Key Features

We are providing ECTD Manager Software to our clients with the following details:
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

Established in 2014, Prelude Regulatory Services has made a name for itself in the list of top service providers of Software in India. Prelude Regulatory Services is listed in Trade India's list of verified companies offering a wide array of ECTD Manager Software, etc. Contact here for Software in Ahmedabad, Gujarat.

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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