SPLR4-Creation
In SPL, forms 2656, 2657 and 2658 are now to be replaced with an electronic submission using SPL R4 format. These forms are:
For details, visit KnowledgeNET...
From July 2009, FDA has made it compulsory to submit the above forms using SPL R4 format. We provide the quick and easy service for creation of all three forms.
Also, SPL R3 can be converted to SPL R4 in easy and accurate manner and in quickest time possible. SPL uses Extensible Markup Language (XML), which has specific guidelines and the standards approved by Health Level 7 (HL7). Creating SPL in XML form, or using a software to generate an SPL is a complex task. It is possible that sometimes SPL cannot get validated if one doesn't have knowledge of SPL Guidelines and XML.
We provide you services for creating or converting to SPL R4 format for FDA submission.
We offer SPL R4 services where it ensures accurate transfer of the Labeler, Establishment Registration and Product Information into FDA compliant and validated SPL XML structure.
For details, visit KnowledgeNET...
- NDC Labeler Code Request (replaces Form 2656)
- Establishment Registration (replaces Form 2656)
- Product Listing/Labeling (replaces Forms 2657, 2658)
For details, visit KnowledgeNET...From July 2009, FDA has made it compulsory to submit the above forms using SPL R4 format. We provide the quick and easy service for creation of all three forms.
Also, SPL R3 can be converted to SPL R4 in easy and accurate manner and in quickest time possible. SPL uses Extensible Markup Language (XML), which has specific guidelines and the standards approved by Health Level 7 (HL7). Creating SPL in XML form, or using a software to generate an SPL is a complex task. It is possible that sometimes SPL cannot get validated if one doesn't have knowledge of SPL Guidelines and XML.
We provide you services for creating or converting to SPL R4 format for FDA submission.
We offer SPL R4 services where it ensures accurate transfer of the Labeler, Establishment Registration and Product Information into FDA compliant and validated SPL XML structure.
- We offer services to help you out for creation and submission of SPL compliant to FDA
- As a client you do not have to buy or invest in technology. You just need to avail our conversion services and pay per use basis
- Simple two steps to achieve FDA compliant SPL conversion - provide Label content either in PDF or XML (if innovator has already provided) with the modifications expected in the same and find full text XML which comply to FDA standards
For details, visit KnowledgeNET...