Electronic Submissions Publishing


SPL Conversion Services


Freyr has extensive experience of converting and creating SPL XML files fully compliant with the SPL guidelines. Freyr SPL Conversion Services include creation of SPL submission packages to FDA for the following types of SPL documents:

  • NDC labeler Code Registration
  • Establishment Registration
  • Drug Listing & Content Labeling

Freyr’s SPL team supports companies in eSubmission Gateway Setups and provides guidance in creating validated SPL Submission Packages. This includes the delivery of validated SPL R4 Submission Packages with SPL4 documents in an XML file as copies, delivered to the customer and uploaded to the FDA submissions gateway respectively.

For every label conversion assignment, our deliverable package to our customer provides:

  • An FDA-Ready SPL package which can be submitted directly as required to the FDA. This package contains the converted XML file, associated molecular images and all other relevant images.
  • A Conversion Service Worksheet providing transparency to the approach followed during conversion.
  • A Conversion Service Report providing summary of tasks executed during the conversion.

eCTD Submission Services


Freyr eCTD Submission Services include

  • Submission Plan Development
  • Submissions Document Development
  • Submissions Compilation & Assembly
  • Submissions Review & Delivery

Submissions Plan Development:

Our team works with customers to understand their submission needs and develop an effective submissions plan. We use our submission plan templates to capture submission components, submission metadata and the navigation structure of documents including hyperlinks and bookmarks.

Submissions Document Development:

Creating electronic submission-ready documents is a core component of the submissions activity. It includes document level & report level formatting, verification of conformance to regulatory agency guidelines, and creation of granular submission components and documents.

Submissions Compilation & Assembly

Compiling submission components and assembling the components in eCTD format includes the following:

  • Submissions Module Creation
  • Submission Metadata Compilation
  • Life-Cycle Management
  • Leaf Documents Compilation
  • Leaf Metadata Compilation
  • Study Tagging Files (STF) Creation
  • STF Attributes Management

Submissions Review & Delivery

Freyr eSubmissions team has extensive experience in building validated submissions packages that are agency acceptable. Key quality and validation activities include:

  • Backbone XML Validation
  • Checksum Verification
  • Manual QA/QC on Individual Modules
  • Manual QA/QC on Complete Dossier
  • Submission Metadata Verification
  • Burn CD/DVD Master
  • Reload Submission and Re-validation
  • Send the CD/DVD to customer for review


Testimonials

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