Client Overview:
Client Overview:A leading pharmaceutical company approached us with an urgent challenge: their Structured Product Labeling (SPL) submission was rejected by the FDA due to formatting errors, missing metadata, and compliance gaps. With tight deadlines and regulatory pressure, they needed a quick and effective solution.
Our Approach:
🔹 Conducted a detailed audit of their SPL files to identify errors.
🔹 Corrected XML structuring and ensured alignment with FDA’s HL7 SPL standards.
🔹 Implemented automated validation checks to catch issues before submission.
🔹 Provided ongoing support for post-approval updates and compliance.
The Result:
A successful SPL submission with zero errors.
Faster FDA approval, avoiding costly delays.
A structured process for future SPL compliance.