Structured Product Labeling Services for Rx, OTC and Biologics
SPL Services by Reed Tech make electronic submission compliance simpler and efficient for manufacturers and distributors of drug and biologic products
Industry-Leading Subject Matter Expertise
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 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.
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 Listing for Rx, OTC and Biologic Products, Content of Labeling Review Submissions, Labeler Code Request/Registration, Establishment Registration, GDUFA Self-Identification.
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 take the trouble out of collecting, validating and converting your lot distribution data.
Health Canada XML Product Monograph
Health Canada will start to accept drug labels in XML Product Monograph 2016 format on a “by request” basis April 1 – July 31, 2020, with a possible full launch to begin Fall 2020 and mandatory requirement 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 U.S. 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.
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.
Structured Product Labeling (SPL) will continue to evolve and expand throughout the industry. Created to increase the reliability and effectiveness of communication across organizations, SPL is a defined labeling structure used for global standardization between all entities of the healthcare system. And with so many parties within the healthcare system relying on accurate information, it is problematic for one party to misinterpret others’ 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
June 2009 marked the guidance of the FDA that all organizations who take any part in the life of a prescription products, over-the-counter (OTC), and veterinary products must submit establishment registration and drug listing information in SPL format. This means those companies that prepare, propagate, compound, process, package, analyze or import these products must all follow SPL submission protocols.