SPL Services for Rx, OTC & BiologicsElectronic 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:
- Drug labeling and listing for Rx, Veterinary, OTC, Homeopathic and Biologic Products
- Annual Blanket-No Change Certification
- NDC/NHRIC Labeler Code Request/Registration Establishment Registration and annual maintenance
- GDUFA Self-Identification
- Lot Distribution Reporting (LDR)
- Electronic Submissions Gateway (ESG)
- Templates for media output for downstream use of SPL-XML for product use documentation, patient or marketing materials
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
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