SPL PORTAL

Pharmaceutical 
and Medical Device

Pharmaceutical and Medical Device compliance functionality for FDA Structured Product Labeling messaging. SPL Portal is a web-based solution permitting your regulatory staff, designers, and administration to pool resources in real time when creating and updating pharmaceutical labeling or medical device data in a structured authoring environment, while allowing for the content to be exported to Microsoft Word and PDF format. 

 

ESM PORTAL

Product
Information (EU)

Provides functionality for pharmaceutical companies that market products in the EEU to comply with the European Medicines Agency (EMA) requirement for submission of information on Medicines by marketing-authorization , holders. Intagras’s ESM Portal creates a central repository allowing pharmaceutical companies to create, edit and manage ESM submissions through the entire life-cycle for regulatory compliance.

 

GDT PORTAL

Global
Implementation

Global Decision Tracking (GDT) Portal is a web-based software providing decision tracking, reporting, and data entry capabilities for pharmaceutical companies. GDT supports unlimited global, milestones, and users to manage the industry standard labeling implementation process. In addition, the software is completely configurable, ensuring a seamless integration and interface with other systems.

RMT

Request
Management

Request Management Tracking (RMT) application allows pharmaceutical companies the ability to trace all implementation requests from the point of identification to the point of delivery.

 

Product Spotlight: SPL PORTAL

    

 

“Intagras is a great company to work with, they strive to always listen and understand your particular needs.  They stay abreast to the changes in the regulatory world and are innovative in their solutions.”

Director Strategic Global Labeling, Baxter Healthcare

 

SPL Portal for Pharmaceutical Product Labeling

SPL Portal provides your pharmaceutical company with the ability to create and manage all US labeling content in structured format. This allows your organization to fully unleash the ability to capture and manage all US labeling content and data. SPL Portal provides your regulatory affairs department with the ability to manage and create SPL submission messages for FDA compliance.

top features
    • RLD Update Notification
    • Central XML Repository
    • Automatic Nightly FDA Terminology Updates
    • Full NLM Search
    • Product Listing Notification

learn more

NEWS & EVENTS

09.09.2016

DIA 2016 Global Labeling Conference

Intagras will be sponsoring the 2016 Develop Innovate Advance (DIA) in Washington, D.C. from September 12th to Se...

02.10.2016

2016 GDT and RMT Product Advisory Board Meeting

Intagras will host the 2016 Product Advisory Board (PAB) in the Tampa, Florida area on Thursday, February 11th 2016.  <...

07.01.2015

GDT Version 5.0 Is Now Available

On May 2, 2015, Intagras released version 5.0 of GDT Portal. Many new features were added to this release. Below are three of the ...