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.
eCTD Global 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).
eCTD Global 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
- No Change Notification
- NDC Labeler Code Inactivation
- Establishment Registration
- Establishment De-Registration
- GDUFA Identification (CDER and CBER)
- 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
Benefit of eCTD Global for
eCTD Global 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 SPLIn 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.