Stay on top of regulatory change.
Our regulatory experts provide internal labeling and compliance groups with the deep knowledge, specialized expertise and regulatory interpretation needed to stay compliant and move projects forward.
SPL OUTSOURCING & CONSULTING
Expert SPL Consultants.
Intagras’ SPL experts support your U.S. and Canadian regulatory teams by providing complete outsourcing and consulting for SPL and SPM file creation and ongoing management.
Make better decisions with expert regulatory interpretation.
Regulatory and compliance teams rely on our decades of experience, regulatory connections, and industry foresight to better understand how global authorities will interpret product information.
Leave your SPL/SPM submissions to the regulatory specialists.
Submitting SPL/SPM files on your own can be time-consuming and challenging without the right knowledge. That’s why you need a team of regulatory experts who can handle the submission process for you.
Since 2005, our team of consultants has helped all kinds of organizations with their SPL/SPM submissions. Simply provide us with your Word document, and we’ll take care of the submission and error processing to ensure your file is approved.
Save time with CBER Lot Distribution Report outsourcing.
It’s no secret that CBER Lot Distribution Reporting (LDR) is a strenuous process that takes valuable time away from your other responsibilities. But what if you could outsource your LDRs to professionals who can effectively transform your information into compliant SPL files?
With Intagras, you can. All you have to do is fill out a spreadsheet with your lot distribution data, and we’ll convert that information into a workable SPL file. This simple process helps to alleviate your workload and keep your process moving forward.
Streamline your submissions with reliable SPL services.
Intagras SPL file creation services help you take the guesswork out of submissions. We work with your organization’s regulatory team to create the following submission files in XML format:
- Rx products
- OTC products
- Bulk products
- Establishment registrations
- NDC labeler codes
- Lot distribution reports
- Wholesale drug distributor/3PL registration
- Blanket no change certification
- Health Canada SPM
Need submission support?
Talk to us.
Want to learn more about our SPL outsourcing and consulting work? Talk to one of our experts today.
