FDA Structured Product Labeling (SPL) Preparation
FDA requires Structured Product Labeling (SPL) — an XML-based format — for drug listing, establishment registration, and NDC submissions. LMG prepares error-free, submission-ready SPL files powered by our proprietary LMG SPLmatrix™ platform.
FDA ESG-Compatible XML
LMG SPLmatrix™ Technology
3–5 Day Turnaround
Since 2009
About FDA SPL Preparation
Structured Product Labeling (SPL) is the FDA’s mandatory XML-based document standard for submitting drug information to the FDA’s electronic systems under 21 CFR Part 207. All drug companies registering facilities or listing products in the United States must submit SPL files through the FDA Electronic Submissions Gateway (ESG).
Incorrect or malformed SPL files are one of the most common causes of registration rejections and delays. LMG’s proprietary LMG SPLmatrix™ platform eliminates these errors by automating the entire SPL generation process with built-in FDA schema validation — ensuring first-time acceptance.
Our SPL preparation services cover:
- Drug Establishment Registration (21 CFR 207)
- Drug Listing & Annual Updates (21 CFR 207.57)
- NDC Labeler Code Applications
- OTC Drug Product Listing
- Prescription Drug Product Listing
- Active Pharmaceutical Ingredient (API) Listing
- Structured Dosage Form & Route of Administration Coding
- FDA ESG Submission, Tracking & Confirmation
At Liberty Management Group, our regulatory team handles the entire SPL workflow — from data collection and XML generation through FDA ESG submission and confirmation — using LMG SPLmatrix™ for zero-error submissions.
Why Clients Choose LMG for SPL
Proprietary LMG SPLmatrix™ Platform
Built in-house by LMG — always current with the latest FDA SPL schema. No third-party tools.
First-Time Acceptance Rate
Pre-submission schema validation catches errors before they reach FDA — minimizing rejections and delays.
Full-Service from 150+ Countries
Foreign manufacturers get SPL preparation + U.S. FDA Agent service in one engagement — no separate vendor needed.
Resubmissions at No Extra Charge
If FDA returns a technical rejection, LMG corrects and resubmits at no additional cost to you.
How SPL Preparation Works at LMG
Our streamlined 4-step process — powered by LMG SPLmatrix™ — ensures your SPL submission is accurate, validated, and submitted on time.
Step 1 — Data Collection & Review
We provide a structured intake form to collect all required product and facility data: establishment information, product names, dosage forms, routes of administration, active and inactive ingredients, NDC numbers, and labeler code. Our regulatory team reviews your existing labels and prior registrations before proceeding.
Step 2 — SPL Generation via LMG SPLmatrix™
Our regulatory specialists input validated data into LMG SPLmatrix™, which generates FDA-compliant SPL XML files. The platform automatically applies current FDA terminology standards (SNOMED CT, FDA-maintained code systems) and validates output against the current FDA SPL schema — catching errors before submission.
Step 3 — Client Review & Sign-Off
You receive a human-readable summary of the SPL content for your review and approval. Our team addresses any queries before submission. For new clients, we confirm your product and facility data is complete before LMG submits via our registered FDA ESG account.
Step 4 — FDA ESG Submission & Confirmation
LMG submits your SPL file directly to the FDA Electronic Submissions Gateway (ESG). You receive the submission confirmation ID and, upon successful processing, the updated FDA registration record. We handle all error responses and resubmissions at no additional charge.
Related Drug Regulatory Services
LMG provides end-to-end FDA regulatory support for drug manufacturers entering or operating in the U.S. market.
Drug Establishment Registration
Register your drug manufacturing facility with FDA under 21 CFR 207. Required for all domestic and foreign manufacturers before marketing in the U.S.
NDC Labeler Code
Obtain your FDA National Drug Code (NDC) Labeler Code — required to list your drug products in the FDA database and print NDC numbers on labels.
Drug Listing & Renewal
List your drug products with FDA and maintain annual renewals using LMG SPLmatrix™ to keep your registration active and compliant.
Drug Label Review
Expert compliance review of OTC and prescription drug labels against FD&C Act requirements — Drug Facts panel, monograph requirements, and marketing claims.
eCTD Conversion & Submission
Convert your drug dossier to FDA-required eCTD format and submit to FDA using LMG eCTD Pro™ — LMG's proprietary eCTD publishing platform.
U.S. FDA Agent Service
LMG serves as your designated U.S. FDA Agent — a legal requirement for all foreign drug manufacturers marketing products in the United States.
SPL Preparation — Frequently Asked Questions
Common questions about FDA Structured Product Labeling (SPL) requirements and the LMG SPLmatrix™ process.
What is Structured Product Labeling (SPL)?
Structured Product Labeling (SPL) is the FDA-mandated XML-based document standard for submitting drug product information to FDA’s electronic systems. It is used for drug establishment registration, drug listing, NDC labeler code applications, and related submissions through the FDA Electronic Submissions Gateway (ESG) under 21 CFR Part 207. All SPL files must conform to the current FDA SPL schema.
When is an SPL file required by FDA?
SPL is required for: (1) Drug establishment registration and renewal under 21 CFR 207; (2) Drug listing — initial listing and annual updates under 21 CFR 207.57; (3) NDC labeler code applications; (4) OTC and prescription drug product listings; (5) Homeopathic drug listings; (6) API (Active Pharmaceutical Ingredient) listings. Both domestic and foreign drug manufacturers must comply. Foreign manufacturers must submit through a U.S. FDA Agent.
What is LMG SPLmatrix™ and why does it matter?
LMG SPLmatrix™ is Liberty Management Group’s proprietary software developed in-house for FDA SPL preparation. It automates the generation of valid, schema-compliant SPL XML files from structured product data, runs pre-submission validation checks, and submits directly to the FDA ESG. This eliminates formatting errors, missing mandatory fields, and incorrect code system values — the most common causes of SPL submission rejection. Because it is built and maintained entirely by LMG, the platform is always current with the latest FDA SPL schema updates.
Can foreign drug manufacturers submit SPL without a U.S. Agent?
No. Foreign drug manufacturers must designate a U.S. FDA Agent before submitting registration or listing information to FDA. The U.S. Agent is the official point of contact between FDA and the foreign manufacturer. LMG provides both U.S. Agent services and SPL preparation via LMG SPLmatrix™, offering a complete solution for foreign manufacturers entering the U.S. market.
How long does SPL preparation take at LMG?
Using LMG SPLmatrix™, our team typically delivers completed, validated SPL files within 3–5 business days from receipt of all required product and facility data. Expedited service is available upon request for urgent registration deadlines. Multi-product portfolios are scoped individually — contact us for a timeline estimate.
What happens if FDA rejects the SPL submission?
LMG monitors all submissions through the FDA ESG and handles all error responses at no additional charge. If FDA returns a technical rejection, our team analyzes the rejection reason, corrects the SPL file in LMG SPLmatrix™, and resubmits promptly — usually within 1 business day of receiving the FDA response.
Does SPL preparation include the physical drug label?
SPL preparation and drug label review are separate services. SPL preparation creates the XML submission file for the FDA database. Drug label review is a compliance audit of your physical product label against the FD&C Act, OTC monograph requirements, Drug Facts panel rules, and marketing claim standards. LMG offers both — contact us to bundle them at a reduced combined fee.
Ready to Submit Your SPL Filing?
LMG SPLmatrix™ prepares your FDA Structured Product Labeling files with zero-error accuracy. Let our regulatory experts handle everything — from data collection to ESG submission and confirmation.
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