Structured Product Labeling

The Structured Product Labeling (SPL) is a document mark up sandard approved by Health Level Seven (HL7) and accredited by the American National Standards Institute (ANSI) . SPL in XML format is adopted by FDA as a mechanishm for exchanging product information.

PharmaReg offers comprehensive SPL conversion services for:

• Drug Product Labeling and Listing

• Establishment Registration

• GDUFA Self-Identification

• NDC/NHRIC Labeler Code Requests

• Drug Labeling (Rx, OTC and Compounded)

• Annual Banket No Change Certification

• Lot Distribution Reporting (LDR)