Structured Product Labeling (SPL) is a document markup standard approved by Health Level 7 and adapted by FDA as a mechanism to exchange product information.
Ever since FDA released SPL version 4 guidelines it has been made mandatory to submit Facility Registrations, Labeler Code Requests and Drug Listings in SPL format.
Team Tranquil is helping pharmaceutical companies prepare and submit product labeling in SPL format since 2005
What we do?
- Help our clients obtain and setup E-Mail ID to be able to communicate with FDA.
- Help setup Electronic Submissions Gateway (ESG) Accounts.
- Prepare Facility Registrations in SPL format and help submitting the SPL through ESG web site.
- Prepare NDC Labeler Code requests
- Team Tranquil help convert the labeling documents in SPL format for our clients.
- We will make sure proper versioning of SPL documents were maintained and help in submission of annual Drug Listings of all approved products.
Download our FDA Electronic Submissions Presentation