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SPL Services for Rx, OTC and Biologics

SPL Services for Rx, OTC and Biologics

SPL Services for Rx, OTC and Biologics

SPL Services by Reed Tech make electronic submission compliance simpler and less time consuming 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)

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.

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 more than 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 conversion and submission services to support distributors of prescription drug samples in fulfilling the mandate of the Affordable Care Act Section 6004 to submit distribution reports electronically in an eXtensible Markup Language (XML) format.

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