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pharmaREADY® SPL
Comprehensive Structured Product Labeling to support label creation and management and establish registration and NDC Labeler Code
What is Structured Product Labeling (SPL) and how can it help your business?
The US Food and Drug Administration (FDA) defines SPL as ‘a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.’ By implementing an SPL module, you not only meet FDA expectations, but also improve the quality and efficiency of your operations. It’s a strategic investment in smarter regulatory management and long-term success.
pharmaREADY® SPL is an end-to-end web-based Structured Product Labeling and Management tool that supports the compliant conversion of labeling.
At Navitas Life Sciences, our highly qualified group of medical and labeling experts offer end-to-end labeling services throughout all phases of labelling, from clinical labeling during the early stages of clinical research through post-marketing labeling. We adopt robust QC checklist to ensure right first time. To date we have delivered >150,000 SPLs including life cycle maintenance.
The SPL module provides:
- A user-friendly web-based interface with no plug-in required
- Full compliance with the Physician Labeling Rule (PLR) and with SPL R4 Schema and Guidelines
- A complete workflow for all stakeholders
- Ability to reuse content by creating custom templates
- Labeling Life Cycle support as per the SPL specifications
- Reference code look-up for highlights and drug listing data elements
- Automatic conversion from SPL to PLR
- Facility to easily create tables, footnotes, and ordered lists.
pharmaREADY® SPL supports US FDA, Health Canada, and REMS
We include both Establishment Registration and NDC Labeler Code as standard
Available as an independent product, or as part of an integrated package with our other modules, pharmaREADY® SPL is available for
Pharmaceuticals
Biologics and Biosimilars
Medical Devices
Generic Drugs
