eWAY-eCTD Solutions


Structure Product Labelling- SPL

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); 

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.

eWAY-eCTD SOLUTIONS 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).

eWAY-eCTD SOLUTIONS 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.

This is an xml base service, where we take labeling data in different format and convert it into the xml document as per the USFDA guidelines and specifications. This service covers all the types of documents which are required by USFDA.