SPL Services for Rx, OTC & Biologics

Electronic Drug Registration and Listing (eDRL)

55k+ SPL electronic drug labeling

submissions filed with the FDA

Simplify electronic regulatory submission compliance for drug and biologic products

Reed Tech serves more than 1,000 drug product manufacturers and distributors with solutions and services to manage product listing, establishment facility and labeler company data across multiple teams with a secure and validated cloud-based solution.

Electronic Drug Registration and Listing (eDRL)

Ensure regulatory compliance. Our experts can remove confusion around SPL and XML formatting. Meet FDA’s expectations and prevent technical issues or errors that extend your submission process. Manage product listing, establishment facility and labeler company data across multiple teams with a best-in-class solution.

Based on your use case, this solution is available within a secure cloud-based platform or by an ‘outsourced’ service model available as conversion and labeling needs arise. Choose which use case best suits your team’s needs and expertise.

    Conversion and Submission Services

    Reed Tech offers conversion and submission services by expert staff to guide manufacturers and distributors of drug and biologic products through the FDA’s eDRL SPL process with guaranteed 100% accuracy:

    Health Canada XML Product Monograph

    Health Canada will start to accept drug monographs in XML format on a “by request” basis April 1 – July 31, 2020, with voluntary launch to begin by Spring 2021.
    Reed Tech knows the Canadian system first hand. For the past two years, we have been working in partnership with two large international drug product manufacturers, in pilot activities with Health Canada, to help establish and test its new XML PM program.
    We have provided XML Structured Product Labeling (SPL) services for US FDA drug labeling to 1,000+ pharmaceutical companies since 2005. We can support your conversions of product monographs to the XML PM format as required by Health Canada.

    Lot Distribution Reporting (LDR)

    Beginning in June 2015, manufacturers of products distributed in the U.S. under a Biologics License Application (BLA) are required to submit lot distribution report data to the FDA electronically every six months. The mandate requires LDRs to be submitted in Structured Product Labeling (SPL) format and incorporated into a BLA supplement eCTD submission. Because this process can be difficult and lengthy, the Reed Tech LDR solution is designed to reduce the burden of collecting, validating and converting your lot distribution data.

    ACA 6004 Drug Sample Distribution Reports

    Reed Tech offers XML conversion and submission services to support distributors of prescription drug samples. In accordance with the mandate of the Affordable Care Act Section 6004, Drug Sample Transparency Act specification, pharmaceutical manufacturers and distributors must now submit distribution reports electronically in an eXtensible Markup Language (XML) format. Reed Tech is ready to help.

    FDA SPL – Structured Product & Drug Labeling Composition Process

    Gain increased control and create print and web-ready files directly from SPL. With labeling composed in XML, Reed Tech offers a process to use the Content of Labeling portion of the FDA-accepted SPL Drug Listing file as the source for:

    • Manufacturing Package Insert (PI)
    • Marketing media-for print or advertising use
    • Med Guide
    • Patient Package Insert (PPI)
    • Product Web Pages

    What Is SPL?

    Structured Product Labeling (SPL) is a Health Level Seven (HL7) International standard for regulatory guidance documents as a method for communicating product and facility information. Accepted by the Food and Drug Administration, SPL enhances the cohesiveness and honesty of product information because it requires reliable structure and standardized terminology. SPL documents consist of not only the content of labeling (text, figures, and tables) but also information about the product (drug listing data elements) that is readable by machines.

    The SPL specification was created to assure that there was a consistent way to develop labeling content. By using an established method for product labeling, enhancements and improvements can be attained throughout every step of the process, from the creation to the distribution of labeling content by industry and health authorities. The labeling of products is a crucial part of product life cycle management.

    reedtech.com/spl

    The procedure of product labeling is detailed, complicated, and closely monitored. The content that the product label contains is very precise, especially regarding its safety data and adverse effects. With so many parties within the healthcare system relying on accurate information, it is problematic for one party to misinterpret another’s message. SPL solves for clear communication with regulated classifications. Many FDA divisions have required SPL since June 2009, including Biologics (CBER), Veterinary (CVM), Office of Nonprescription Products (ONP), and Medical Devices (CDHR). Other divisions, like the Center for Drug Evaluation and Research (CDER), have followed the requirement since October 2005.

    As an eCTD publisher I have worked with Reed Tech for nearly 10 years. They are my go-to for all things related to SPL and drug product listings as they are truly experts in a narrow but critical field. Highly recommend!

    –Operations Manager with Parexel/Liquent

    Learn more about Structured Product Labeling Solutions & Services for Rx, OTC and Biologics