Registrations & Listings
Structured Product Labeling (SPL)
Structured Product Labeling (SPL) is an FDA‑adopted document markup standard, approved by Health Level Seven (HL7), used to exchange regulated product and facility information electronically.
SciRegs International, Inc. helps clients meet FDA SPL requirements efficiently and accurately—without the need to purchase specialized software or invest in extensive SPL training. Our experienced regulatory professionals manage the technical complexities of SPL creation, validation, and submission, allowing your team to stay focused on core regulatory strategy.
SPL Services
-
FDA Facility Registration
-
Drug Product Registration and Listing
-
Annual Blanket “No Change” Notifications
-
Labeler Code Assignment
-
Medical Device Facility Registration
-
Medical Device Listing
With SciRegs® as your regulatory partner, you gain reliable, compliant SPL submissions supported by deep FDA expertise and practical execution—reducing risk and administrative burden while ensuring ongoing registration and listing compliance.