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.

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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.

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.

making better decisions

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.

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