Label Conversion Services (SPL-PLR)

Step 1: Collect Label Content

Label Content has the following components:

• Narrative Content (Full Prescribing Information): Clients can provide this content in Word, PDF, Native PDF or any other custom format.
• Highlights (For PLR only): Clients can provide this content in Word, PDF, Native PDF or any other custom format.
• Image content: Molecular images, company logos, etc., can be provided as image files (jpeg, bmp, tiff or any other custom format).
• Drug Listing Metadata: Can be provided using our pre-defined easy-to use template which captures all the required compound data information. Please do send us an email or call us to get a sample drug listing metadata template.
• Highlights Data Elements (For PLR only): be provided using our pre-defined easy-to-use template which captures all the required Highlights data information. Please do send us an email or call us to get a sample Highlights Data Element template.

A secure and validated environment is provided to our customers for label content communication.

Step 2: Convert Label to SPL-PLR

Your label goes through the following conversion assembly line:

For PLR labels, the following additional steps are needed:

• Author Full Prescribing Information and Highlights Text.
• FPI and Highlights Narrative Text Analysis
  Identify the Data Elements to code
  Coding Highlights Data Elements (HLDE)
• XML Preview
• QC of HLDE
• Generate SPL-PLR compliant XML

Every one of the above processes is well established and recorded. The label conversion services are performed in a secure and validated environment. Our technical team involves specific user roles responsible for the processes mentioned above. Our content conversion experts have extensive domain expertise in Regulatory Labeling Requirements and are trained in providing in-depth quality assurance.

We provide detailed Conversion Reports and Conversion Worksheets to our customers enabling complete visibility to our conversion activities. Please do send us an email or call us to get a sample Conversion report and Conversion Worksheet.

Step 3: Deliver Label in SPL

The following are provided as part of our deliverable package to our customer for every label conversion assignment:

• FDA-ready SPL package as required by FDA which can be submitted directly to FDA. This package contains the converted XML file, associated molecular images and other images.
• Conversion Service Worksheet providing transparency to the approach that was followed in doing the conversion.
• Conversion Service Report providing the summary of the tasks carried out as part of conversion.
• Drug Listing Data Element Form providing the drug listing data elements and the codes.
• Highlights Data Element Form providing the Highlights data elements and the codes.

• Overview
• Document Management Solution
• Training Records Management
• eCTD Submissions Management
  • eCTD Submissions Templates
• Structured Product Labeling Management