LexisNexis Life Sciences Labeling & SPL Services helps drug and biologic manufacturers and distributors prepare, validate, and submit labeling using SPL and XML. It supports FDA electronic drug registration and listing (eDRL), Health Canada XML product monograph work, and SPL-driven composition
LexisNexis Life Sciences helps remove confusion around SPL and XML formatting so you can meet FDA expectations and prevent common technical issues. Conversion and submission support guides your FDA eDRL SPL process, including transmission through the Electronic Submissions Gateway (ESG).
Use the Content of Labeling in an FDA-accepted SPL Drug Listing file to produce print and web-ready files for downstream use. This approach supports consistent outputs such as package inserts, medication guides, and product web pages.
LexisNexis Life Sciences provides end-to-end support for Health Canada’s 2020 PM Template and XML standards, from product monograph authoring and labeling migration to XML preparation. Data validation, XML-PM build and check, version storage, and reporting help support compliance tracking and audits.
Need help beyond a single submission? These capabilities cover the hands-on work of formatting, validating, publishing, and maintaining structured labeling across FDA and Health Canada requirements.
Get support for Annual Blanket–No Change Certification, NDC/NHRIC labeler code request/registration, and establishment registration with annual maintenance. Additional services include GDUFA Self-Identification, ACA 6004 drug sample distribution reports, and lot distribution reporting (LDR).
eCTD support can include strategy, project management and compilation, and validation troubleshooting for regulatory applications and updates. PDF and MS Word publishing aligned to ICH and regional authority standards supports deliverables such as Clinical Study Reports.
Create print and web-ready files directly from the Content of Labeling portion of an FDA-accepted SPL Drug Listing file. Outputs can include manufacturing package inserts (PI), medication guides, patient package inserts (PPI), and product web pages.
Services include product monograph authoring, medical writing and labeling migration to the 2020 PM Template, and Health Canada-ready XML preparation. Data validation, XML-PM build and check, version storage, reporting, and eCTD support help prepare for compliant submissions and audits.
Explore our SPL services in CanadaThis service suite is built for organizations responsible for drug and biologic product labeling, listing, and product monograph submissions. LexisNexis Life Sciences supports these teams with structured labeling expertise and submission-ready outputs across FDA and Health Canada workflows.
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We provide regulatory consulting, outsourced Structured Product Labeling Services (SPL) for US FDA product listings, eCTD, US Agent and other drug listing & establishment registration services.
We support medical device manufacturers across the entire product lifecycle, from initial UDI data collection, preparation, and submission to ongoing updates, change management, and post-market compliance.
While the Reed Tech name is being retired, the business has long operated as part of LexisNexis. Customers will continue to work with the same regulatory experts, services, and solutions—now unified within LexisNexis Life Sciences to reflect the broader capabilities and global resources of LexisNexis.
