GLOBAL eCTD PUBLISHING

AND SUBMISSION

Our team of regulatory experts employ proven software solutions to deliver compliant, timely submission components, documents, and valid electronic submissions. We ensure that our experts are compliant with the SPL guidelines and can convert XML, as well as, PDF files on either our software solution or yours. We handle regulatory submissions for adopting technology, processing, managing, labeling and details of any label changes made, including change in content of the formatted label, carton labeling or container labeling using Structured Product Labeling (SPL) standard

 

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  • Clinical Data Interchange Standards Consortium
    (CDISC) and U.S. Food and Drug

  • Administration (FDA) submission data conversion services

  • Scanning services and legacy document conversion

  • Document and report publishing

  • CSR – Report Level Publishing

  • Define files

  • Transport files 

  • Patient profile/narratives

  • Structured product labeling conversion services

We help to prepare all the necessary components for submission.

Get in touch with us today and let us know how we can help you