SPL SUBMISSIONS SOLUTION

SPL Portal.

SPL Portal is the regulatory industry’s first and leading SaaS solution for SPL creation and management. Create compliant, accurate and error-free SPL/SPM files for all existing FDA and Health Canada electronic registrations and listing regulations.

One XML repository for your product labeling.

SPL Portal is a secure web-based application with a central repository that allows pharmaceutical companies to manage and create compliant product labeling solutions. It offers a robust reporting dashboard to deliver relevant data directly to spreadsheets for easy tracking.

Nightly FDA and NLM updates.

SPL Portal automatically downloads the newest updates from the National Library of Medicine DailyMed, the FDA NDC Directory and the FDA SPL Terminologies. This ensures you have up-to-date data available at your fingertips at all times.

Woman working late
Web Audit

Comprehensive audit trail.

All modifications are captured by username and date to ensure your product labeling remains compliant. Additionally, SPL Portal captures content values before and after an update. This creates an audit trail that can be shown to regulatory authorities.

Multiple delivery models available.

SPL Portal offers multiple delivery models to get you up and running fast. You can internally host SPL Portal by your organization or subscribe to the hosted SaaS application. The SaaS model provides immediate global access with no software to purchase or install.

Delivery model

Supports various SPL/SPM files.

SPL Portal supports virtually all the required file types you will need throughout your product label lifecycle:

Need better
regulatory tools?
Talk to us.

Have questions? Need more info? Talk to one of our experts or request a demo of our SPL or Tracking Portal software today.

About Us.

Regulation is a language. From tracking global data standards to SPL/SPM & XML conversion to shifting interpretation and guidance – Intagras helps you make sense of it all with expert regulatory tracking & submission solutions.