5 Expert Tips for Choosing Regulatory Submission Software

Creating SPL and SPM files that are compliant and error-free is key to successful submissions. Regulatory submission software can help to ensure your files are accurate and up to date. In this blog, we look at five tips for selecting the right solution for your needs.

Choose Regulatory Submission Software

What Are Regulatory Submissions?

Regulatory submission software creates Structured Product Labeling (SPL) and Structured Product Monograph (SPM) files that comply with regulatory authorities. SPL files are sent to the FDA in the United States, while SPM files go to Health Canada. SPL files include:

  • Drug listings
  • Establishment Registrations
  • NDC labeler codes
  • Blanket No Change Certifications
  • WDR/3PL
  • Lot Distribution Reports

Organizations leverage regulatory submission software to guide them through the complex world of regulatory submissions. Guidance constantly changes, making it challenging to stay current on the latest reforms. Regulatory submission software removes the guesswork and helps ensure that SPL and SPM files comply with the latest rules and regulations.

But knowing which regulatory submission software to choose is a challenge in itself. With so many options available, how can you know which is right for you and your team? Here are five tips from the experts to help you make a winning decision.

1. Consider the Onboarding Process

When you’re researching regulatory submission software, look at the onboarding process. Is it slow and confusing? Fast and efficient? How easy will it be for your team to get up to speed?

In general, the length of the onboarding process depends on a couple of factors. First, there’s client size. If you have only a small collection of products, it’s easier to get onboarded quickly. But if you have hundreds of products, it can take longer for you to get set up.

Another factor is whether the regulatory submission software allows for importing files. The import feature allows you to import an existing SPL file and swiftly make any necessary updates. This makes the onboarding process seamless, and depending on your migration method, you could be up and running the same day you sign up.

2. Look for Flexibility

Another factor when considering regulatory submission software is flexibility. Does the software have to be installed on your computer, or is it web-based so you can use and access it virtually anywhere? Can you submit your SPL files through the software, or must you transfer them to your personal account to send documents?

Also, does the software company offer services to convert directly from the negotiated Word document to SPL? This process can save significant time during the initial conversion, especially if your staff is already strained.

3. Check for Templates

Templates are a must-have for any regulatory submission software. That’s why virtually every solution has them. If they don’t, it could be a red flag that the software company isn’t taking submissions seriously. Therefore, check that the software offers templates for various regions that can be customized and reused as needed.

4. Examine Integrations

When working with regulatory submission software, it helps to have a single source of truth with up-to-date information at your fingertips. This is possible with the help of integrations. They bring all your data into a central repository that allows you to manage and create compliant product labeling solutions.

With all your data in one place, you can easily search for files and run reports to check progress. This saves time and gives you peace of mind that the work you’re doing won’t have to be redone later because it will be compliant and accurate.

5. Ensure Support is Available

Any reputable regulatory submission software will offer support to help you with any SPL or SPM file concerns. In addition to standard help desks, support should involve the ability to speak with an expert who can edit files on your behalf and answer any regulatory questions you may have. It’s also beneficial if they can train you on their platform so you get a first-hand learning experience.

The regulatory landscape is always evolving, making it difficult to keep up with and understand how changes are impacting your product. Having a regulatory expert on speed dial allows you to keep your projects compliant and moving forward. Some even maintain good relationships with regulatory authorities, like the FDA, to ensure they can resolve any potential submission issues fast.


The right regulatory submission software can make the job of remaining compliant while working in the regulatory space much less painful. But solutions are not all created equal. In assessing your options, pay attention to onboarding requirements, flexibility, templates, integrations, and last but certainly not least, the nature and frequency of support.

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

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