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Our SPL conversion services include the creation of SPL submission packages to the FDA for:
- NDC labeler code registration
- Establishment registration
- Drug listing and content labeling
The SPL team supports eSubmission gateway setups and guides in creating validated SPL submission packages. Our validated SPL R4 submission packages include SPL R4 documents in an XML file for delivery to the customer and uploading to the FDA submissions gateway.
For every label conversion assignment, our deliverables include:
- An FDA-ready, submittable SPL package containing the converted XML file, associated molecular images, and all other relevant images
- A conversion service worksheet providing transparency on the conversion approach and a conversion service report summarizing tasks executed during the conversion