NVIFDA
+66 65 669 4888

KNOW ABOUT NVIFDA

Background

NVIFDA is an eCTD submission management software with the collaboration of National Vaccine Institute (NVI) and Thai Food and Drug Administration (Thai FDA) in order to transform pharmaceutical product registration process from paper-based to electronics-based. NVIFDA has been developing since 2015 with the collaboration of government authorities and pharmaceutical companies.

About electronics submission

System Overview

NVIFDA has been developing based on web architecture which is able to work on cloud, a customer’s local network (client-server) and a standalone version. With the highest security aspect, the latest version of NVIFDA was designed in an offline mode that allows user to manage, compile, review, validate and review document completely while the internet connection is not required. All documents are stored and kept in user’s server or PC under customer’s security policy.

Currently, the software supports document preparation based on eCTD specification version 1.0 Thailand

Tools

We make it simple, providing best solutions

Businex - How we work
File Upload

Simply import files into the software by just drag and drop

Businex - How we work
User Management

In addition to authentication, it can activate or deactivate each users to reach specific identities (dossiers)

Businex - How we work
Validate

Ensure that no invalid submission are generated.

Businex - How we work
Publish

Easily export file in eCTD format, the latest version of submitted files and NeeS

Businex - How we work
File Arrangement

Manage and arrange the prepared submission documents into the pre-set modules

Businex - How we work
Hyperlink

Create the hyperlink from one document to the others in a single panel

And more ….

We are dedicated to provide you with the best software solution that will help you to move to electronics submission effortlessly

Coming Soon (New Features)

  • ✔ Import function : Import eCTD-compatible files into NVIFDA
  • ✔ NeeS : export files with bookmarks.

Our competitive points

  • ✔ Valuable price in terms of software license and maintenance fee
  • ✔ Rapid compliance with latest regulatory changes according to Thai FDA
  • ✔ Compliance with your security policy due to an offline version (on premise)
  • ✔ Training and technical support are provided by Thai staffs
Lite
MULTI-USER
50,000 THB
This is the starter package
starts with 2 e-identities
Plus
MULTI-USER
80,000 THB
This is the basic package
starts with 4 e-identities
Unlimited
MULTI-USER
250,000 THB
Unlimited Usage

Remarks

  • • The price is inclusive of initial installation, the 1st year warranty and the 1st time training.
  • • VAT is exclusive.
  • • [Option] 25,000 THB/e-identity (for Lite and Plus)
  • • Maintenance Fee 40,000 THB / Year (2nd year onwards)
  • ** We reserves the right to change price and terms of service in the future

HIGHLIGHT

  • • Unlimited number of dossier publishing.
  • • Unlimited number of users.
  • • All data protection and privacy is subject to the customer’s policy.
  • • The software can be installed at both standalone (PC) and client-server (Server)

About Warranty and Maintenance Service

  • • Warranty and Maintenance service is to stay up the date of the latest version of NVIFDA including technical support.
  • • Basically, software maintenance will be conducted via remote software such as AnyDesk or TeamViewer with the prior permission of customer.
  • • The service fee will be charged from the 2nd year onwards.