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

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NEWS & EVENTS

10.26.2017

Intagras identified as a Top 10 Solution Provider

Intagras was identified by Pharma Tech magazine as one of the Top 10 Pharmaceutical Compliance Solution Providers for 2017. &n...

10.21.2016

Regulatory Submissions, Information, and Document Management Forum 2017

Intagras is proud to be sponsoring the 2017 Develop Innovate Advance (DIA) Regulatory Submissions, Information, and Document Manag...

10.13.2016

Celgene Corporation chooses GDT Portal for global labeling implementation tracking

Intagras is pleased to anounce that Celgene has joined the ranks of our Global Decision Tracking (GDT) clientele. Celgene is an in...