Structured Product Labeling

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Structured Product Labeling (SPL) Services

SPL is a markup standard approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.

Structured Product Labeling (SPL) in XML format is mandated by FDA, applicant has to submit SPL in XML format in labeling section with PDF and Word documents for ANDA, NDA, and BLA submissions.

FDA no longer accepts the NDC labeler code, Establishment Registration and Drug Registration and Listing in paper forms (forms 2656, 2657, and 2658). Applicant must submit in a fully electronic format i.e. SPL XML.

Masuu Regulatory Labeling qualified expertise team has specialization in conversion of FDA compliant & validated SPL files (XML) using package insert / medication guide (clean copy and comparison document).

Masuu Team assist pharmaceuticals, biopharmaceuticals, cosmetic, medical device and healthcare industries to convert their label into to SPL XML format and also manages life cycle of SPL i.e. version control by using all the standard parameter as per FDA specification with complete validation guarantee with day to day service.

SPL conversion services

SPL conversion services include creation of SPL submission packages to USFDA for the following types of submission; will meet client’s needs for eDRLS (Electronic Drug Registration and Listing Systems);
No Change Notification
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
SPL-Conversion

MASUU provides SPL Support to

Benefit of Masuu for SPL Conversion

Masuu Team assists pharmaceuticals, biopharmaceuticals, cosmetic, medical device and healthcare industries to convert their label into to SPL XML format and also manages life cycle of SPL i.e. version control by using all the standard parameters as per FDA specification with complete validation guarantee with day to day service.
Accurate and cost effective service depends on SPL variety i.e. ER, NDC, GUDFA, RX, OTC, Cosmetic etc
Completely and fully FDA compliant and validated SPL
In house pre defined templates for varieties of SPL’s
lifecycle management of SPL (version and set id management)
SPL validation as per FDA compliant and specification (zero error)
Cross review of COL, PDP and DLD section of SPL (Set ID, version No. DUNS number, NDC, Registrant, Labeler and Establishment Information) by Labeling SMEs.

Masuu SPL Flow Chart

Masuu-SPL-Flow-Chart

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