Structured Product Labeling (SPL) for USFDA ANDA, NDA, BLA, Cosmetics and Facility Registration

Structured Product Labeling (SPL) and Structured Product Monograph (SPM) is an XML-based markup standard approved by Health Level Seven (HL7) and adopted by the USFDA and Health Canada for the exchange of product and facility information. The USFDA mandates SPL in XML format for the submission of labeling sections, along with PDF and Word documents, in ANDA, NDA, and BLA applications. Health Canada has also started accepting SPM for ANDS, NDS, sANDS, and sNDS.

Our professional team boasts unparalleled expertise in offering SPL/SPM conversion services across various product type; Rx & OTC drug listing, API/Bulk Ingredient Listing, Establishment Registration, NDC/NHRIC Labeler Code, GDUFA Self-Identification and Cosmetic MoCRA Registration. With a proven track record of serving over 100 satisfied firms by using our secure and validated cloud-based platform, NextGen SPL.

Our team at Masuu Regulatory Labeling specializes in converting and validating SPL/SPM files (XML) that comply with FDA and Health Canada standards. Using package inserts and medication guides, we create clean copies and comparison documents for conversion. We offer SPL submission packages for various types of submissions to the USFDA, ensuring they meet client needs for the Electronic Drug Registration and Listing Systems (eDRLS):

  • NDC Labeler Code Request
  • NDC Labeler Code Inactivation
  • Establishment Registration
  • Establishment De-Registration
  • GDUFA Identification (CDER and CBER)
  • No Change Notification
  • Out of Business Notification
  • REMS Labeling
  • Drug Labeling (Prescription, OTC, and Compounded)
  • Core Labeling
  • Compounded Drug Reporting
  • Home Use Medical Device Labeling
  • Lot Distribution Data
  • Medical Food Labeling
  • Medicated Animal Feed Establishment
  • Bulk Ingredient Labeling
  • Cosmetic Labeling
  • Homeopathic Labeling
  • Medical Device Labeling
  • Dietary Supplement Labeling
  • Plasma Derivative Labeling
  • Vaccine Labeling
  • Cellular Therapy Labeling
  • Blanket No Change Certification of Product Listing
    • Why Choose Masuu for SPL and SPM Conversion?
    • Accuracy and Cost-effectiveness:
      We provide precise and affordable services tailored to various SPL types, including ER, NDC, GUDFA, RX, OTC, and Cosmetic.
    • FDA and Health Canada Compliance:
      Our SPL/SPM files are fully compliant and validated according to FDA specifications.
    • Pre-defined Templates:
      We use in-house, pre-defined templates for a wide range of SPLs.
    • Lifecycle Management:
      We handle the complete lifecycle management of SPLs, including version and set ID management.
    • Zero-error Validation:
      We ensure SPL validation with zero errors, adhering to FDA specifications.
    • Expert Review:
      Our Labeling SMEs conduct thorough cross-reviews of COL (Content of Labeling), PDP (Principal Display Panel), and DLD (Drug Listing Data Element) sections of SPLs, including Set ID, version number, DUNS number, NDC, registrant, labeler, and establishment information.

    Masuu assists the pharmaceutical, biopharmaceutical, cosmetic, medical device, and healthcare industries in converting their labels into SPL XML format. We manage the entire lifecycle of SPLs/SPMs, ensuring compliance and validation with standards, providing reliable day-to-day services.

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