Lints FDA SPL establishment registration XML before it goes to the FDA ESG: DUNS format, LOINC document type, UUID setId, and the October 1 - December 31 annual registration window. Runs entirely in your browser — nothing is uploaded.
Full version - $29 once: sweep every SPL file in the submission folder and export a dated readiness report · one licence key per person or CI seat · 7-day full refund. A regulatory-affairs consultant bills $100-$200 per hour.
Same engine as the VS Code extension, byte for byte.
This page is the working piece. The full pack has everything below.
Finds the lines the FDA gateway rejects in an SPL establishment registration, and how many days are left in the October 1 - December 31 window.
A regulatory-affairs consultant bills $100-$200 per hour.
Buy the full version — $29It reads an FDA Structured Product Labeling establishment registration XML file in your editor and runs 9 rules against it: the LOINC document type 51725-0, the LOINC code system OID, UUID document id and setId, versionNumber, the eight-digit effectiveTime, the October 1 - December 31 registration window, the lapse clock, and whether every D-U-N-S number is exactly nine digits. Each finding names the line.
Regulatory affairs and regulatory operations staff at US drug establishments - manufacturers, repackagers, relabelers and contract sites - who build or hand-edit SPL establishment registration XML before sending it through the FDA Electronic Submissions Gateway. It also fits developers who generate SPL files from a product database and need a check in the repository.
A generic XML validator checks well-formedness, not that your document code is 51725-0 or that your D-U-N-S extension is nine digits rather than 12-345-6789. A chatbot does not know today's date against the October 1 - December 31 window. The FDA gateway does know, but it only tells you after you have already submitted.
Free, with no key: lint the open SPL XML file against all 9 rules and get every blocking error with its line number. That finishes one file. The licence key adds a different axis - sweeping every .xml file in the submission folder in one pass, and exporting a dated readiness report you keep with the submission record.
A regulatory-affairs consultant bills $100-$200 per hour, and a rejected gateway submission costs a re-check plus a resubmission cycle inside a window that closes on December 31. The full version is $29 once, one licence key per person or CI seat, with a 7-day full refund. The free tier alone finishes one file.
One question, answered by the person who built it. Your email only if you want the answer sent.