voice search
Ectd Manager Software
Share

Ectd Manager Software

Price:

Get Latest Price

In Stock

In Stock

Product Specifications

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

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

Prelude Regulatory Services, Established in 2014 at Ahmedabad in Gujarat, is a leading service provider of Software in India. Prelude Regulatory Services is one of Trade India's verified and trusted names for listed services. With extensive experience in the field of Software, Prelude Regulatory Services has made a reputed name for itself in the market with satisfactory ECTD Manager Software, etc.
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

Related Products

Explore Related Categories

More Product From This seller

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

Report incorrect details

Compare With Similar Products

Buyer Feedback

3

Payment Terms

Letter of Credit at Sight (Sight L/C)

Others

Delivery Time

3-4 Days

1 Week

Supply Ability

10 Per Month

10 Per Month

Packaging Details

Not Applicable

Good

Main Domestic Market

All India

All India

People Also Viewed