FDA / Health Canada Drug Listing Filing Support Services
Do you need help creating and filing labels with the FDA and/or Health Canada? Newbook can help. We provide the following SPL/XML PM related services:
- Creation or update of existing Drug Listing
- Conversion of MS Word or DTP formats to current filing guidance requirements
- 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
Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. for a demonstration and pricing.
