Efficient and cost-effective, the Reed Tech LDR solution enables biologics and vaccine manufacturers to prepare required periodic distribution reports and successfully meet new regulatory challenges

Horsham, PA, April 17, 2015 — Reed Technology and Information Services Inc. (Reed Tech), a leader in regulatory data management, preparation, and submission to the U.S. Food and Drug Administration (FDA), announced today the availability of a new Lot Distribution Report (LDR) service for manufacturers of biologics, including vaccines, that are required to remain compliant with the FDA’s new rule on electronic submission of LDRs.

Used by the FDA to monitor the volume and timing of particular biologics introduced to the marketplace, LDRs are currently submitted as PDF versions of spreadsheet data by manufacturers holding a Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) or the Center for Drug Evaluation and Research (CDER). Per FDA guidance, beginning June 10, 2015, manufacturers of biologic products must submit LDRs to the FDA in an electronic HL7 Structured Product Labeling (SPL) XML format that the agency can process, review, and archive in order to ensure a greater degree of accuracy and reduce reporting errors. The new rule requires biologics manufacturers to submit the specified LDRs every six months, unless a more detailed report or a different schedule is requested by the FDA.

Biologics manufacturers can leverage the deep SPL experience of Reed Tech and its superb customer satisfaction record to remain compliant with these new LDR submission requirements in a cost-effective manner. Complementary to manufacturers’ current internal processes, the Reed Tech LDR solution accepts data from existing systems, which can easily be captured through the use of a Reed Tech data template that contains all the newly defined LDR data fields. The Reed Tech LDR system validates the dataset to current FDA specifications and builds LDRs in the compliant SPL format. Reed Tech will then return the SPL to the manufacturer for inclusion in a BLA supplement.

“We are very pleased to assist biologics manufacturers in successfully meeting these new regulatory challenges,” said Ben McGinty, Senior Director, Business Development – Life Sciences at Reed Tech. “Reed Tech is uniquely positioned to provide this LDR service as a leader in SPL content transformation for the pharmaceutical industry and as a participant in the two CBER pilot programs for LDR submissions. The Reed Tech Life Sciences team gained invaluable insights from the pilot programs, building on our decade of experience in submitting SPL XML data to the FDA. We look forward to applying our expertise to support our biologics customers.”

Biologics manufacturers that would like more information on new FDR mandates can download a free Reed Tech LDR Readiness Kit.