SPL Management

Manage and create FDA compliant submissions.


SPL Portal

For Pharmaceutical Companies

SPL Portal is available as an on-premise, or as a SaaS subscription.  The application is designed with a central repository at its core that stores pure XML content. This is content you define according to your standard operating procedures (SOP) and internal best practices. Essentially, we store the narrative from your previous successful submissions in XML format within SPL Portal’s relational database. Within the Structured Product Labeling database, your XML content is versioned at the section level, enabling centralized updates of the associations created between products, establishments and labelers. Make updates to a contact and the change is propagated across all mapped products. 
This powerful, configurable software allows pharmaceutical companies like yours to effectively and efficiently manage the creation and harmonization of product labeling and all other documentation. You create documents that are accurate, error-free and fully compliant with all existing FDA electronic registrations and listing regulations. This content can be published on demand in both print-ready and web-ready formats. 
There are five significant reasons why SPL Portal from Intagras is the best choice for your organization:
1. Understand that every resource at Intagras is fully focused on understanding the complex relationship between your regulatory affairs department and the FDA. We continually keep the pulse of both these organizations, monitoring changes and modifications to their regulations as closely as you do. When the FDA does make changes, we make changes and your company benefits. 

2. SPL automatically downloads the full contents of the National Library of Medicine’s DailyMed site, as well as the FDA Structured Product Labeling Terminologies every single night. This single feature enables SPL Portal to put the most current available data and information at your fingertips. And we make this massive compendium of information searchable in seconds.

3. We know how quickly the FDA labeling requirements can change and we built powerful notification tools into SPL Portal. If a new product is listed or an existing product changes, everyone who should know about it, does know about it- in seconds.

4. Not only does SPL Portal help you stay compliant with FDA regulations, it also keeps you audit-ready. Changes are captured by user name and date. It also captures common values before and after any updates or modifications. When a change is made, not only do you know it- you can track it and you can prove it.

5. Your organization maintains control of your content at all times, from creation through publication and on to submission. Your data is highly encrypted, ensuring the security of this vital resource.

Structured Product Labeling Portal helps you save time, money and resources, which in turn impacts your ability to market and increase revenues in positive ways. Combine these compelling reasons with the focused customer support and service our valued clients enjoy, and SPL Portal emerges as the preferred choice for Structured Authoring of FDA labeling. For more information, or to schedule a demonstration of this robust software, call Intagras at (813) 226-1863.