FDA SPL Filing Support Services
Do you need help creating and filing labels with the FDA? Newbook can help. We provide the following SPL related services:
- Update existing SPL Labels
- SPL R5-compliant document authoring
- Conversion of SPL R3 Labels to SPL R5 Listings
- Conversion of non-PLR content into PLR structure.
- Data entry for NDC Labeler Code Request, Establishment Registration and GDUFA Self Identification forms
- Drug Listing training and mentoring for in-house SPL submission authors