Overview

As per the United States Food and Drug Administration (USFDA) norms, adopting technology, its processing, managing, labeling and details of any label changes made, including change in content of the formatted label, carton labeling or container labeling have to be electronically submitted using Structured Product Labeling (SPL) standard.

Based on extensible markup language (XML) the SPL facilitates the communication of drug labeling data reliability among various groups such as the FDA, hospitals, prescribing organizations, and doctors, in addition to the general public through the DailyMed.

Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. SPL documents include a header and body. The header includes information about the document such as the type of product, its author and details about its versioning. The body of the document includes product information in both structured text and data element formats. The FDA uses SPL documents to exchange information elaborating various product related topics. 

To assist organizations, Freyr integrates a web-based tool that automates compliance with current SPL and PLR standards as established by the FDA. With an experienced team of conversion specialists and a unique SPL conversion methodology, Freyr ensures accurate label conversion and 100% compliance.

The SPL Submission Process:

Freyr SPL Creation and Submission Process

 

Freyr Expertise

  • Comprehensive SPL conversion services to handle all types of products including prescription drugs, Over The Counter (OTC) products, veterinary medicine, homeopathic products, and bulk ingredients as well as experts to dispatch and publish the SPL in the DailyMed with minimal errors
  • Managing, recognizing, and resolving the errors made while publishing the SPL in the DailyMed
  • Tackling establishment registrations
  • NDC labeler code requests for all categories of drugs
  • Drug labeling, listing, and other drug product submissions
  • Bulk ingredient labeling
  • Managing content of labeling for prescription (human and animal) drug label, OTC, and Biological License Applications (BLAs)
  • Validation of SPL in validator tool and successful publishing of error-free labeling content in the DailyMed through the Office of Compliance (OC)
  • Identifying and defining a flexible delivery plan that can withstand last minute updates
 

Freyr Advantages

  • A project brief that clearly outlines the individual roles and responsibilities, dependencies and other critical aspects for project success communicating project expectations both at the beginning of the project during the “starting up” project phase and at regular intervals during the delivery phase, as well and periodically during the delivery phase
  • Continuous project monitoring and immediate resource ramp up from the rolling bench
  • Proactive training and system access for resources on bench
 
Freyr SUBMIT

Freyr SUBMIT is a complete eCTD software product for the creation, validation, publishing, viewing and reporting of Regulatory documentation for electronic submissions by pharmaceutical companies to Regulatory Authorities.

Learn more about Freyr’s eCTD Submission Solution

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