Label Creation and Management

Navitas pharmaREADY SPL is an easy-to-use, web-based content authoring application. Authoring is as simple as copying and pasting content components from source documents into the editor. The complex content structures, including tables, images, lists, and nested subsections, are easily created with state-of-the-art content handler components.

Navitas pharmaREADY SPL has comprehensive workflow features supporting multi-user authoring, collaborative review, approve, and publish.

  • Narrative Content (Full Prescribing Information): Clients can copy content from Word, PDF, Native PDF or any other custom format.
  • Highlights (For PLR only): Clients can copy content from Word, PDF, Native PDF or any other custom format.
  • Image content: Molecular images, company logos, etc., can be provided as image files (jpeg).
  • Drug Listing Metadata: Can be provided using our pre-defined easy-to use template which captures all the required compound data information. Please send us an email (insert email address here – clickable) or call us to get a sample drug listing metadata template.
  • Highlights Data Elements (For PLR only): Can be provided using our pre-defined easy-to-use template which captures all the required Highlights data information. 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.
  • FDA-ready SPL package as required by FDA which can be submitted directly to FDA (via the gateway?). This package contains the converted XML file, associated molecular images and other images.
  • 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.

Fully Implemented Physician Labeling Rule

Our user-friendly interface with context sensitivity helps make highlights authoring and coding simple and error free. Reference lookups are provided for highlights and drug listing data elements wherever appropriate. The built-in validation engine ensures 100% SPL-PLR compliance.

Content Management, Collaboration, and Granular Authoring

The multi-user label authoring feature supports independent section authoring on a concurrent basis within a label. Users can collaborate and share information during the review and approval processes using the notes feature. The review comments can be generated as printable reports. Role-based security is provided for editing, reviewing, approving, and publishing the labeling content.

Life Cycle Management

Through the use of Life Cycle Management, existing SPL labels can be imported and revisions made. The user can generate the appropriate root ID for each individual section once changes are complete. Automatic version control is provided.

Validation

The FDA requires a label to pass both tier 1 and tier 2 validations and to be 100% SPL compliant. Failure of first-tier validation prevents SPL from loading into ELIPS (Electronic Labeling Information Processing System) used by FDA. Failure of second-tier validation causes the SPL data elements to be flagged for manual review during the labeling review process. It prevents the SPL from being transmitted to NLM (National Library of Medicine).

The Navitas pharmaREADY SPL product has built-in validation which ensures tier 1 validation compliance by checking against the SPL business rules and schema. The tier 2 validation can be done through the FDA Pragmatic validator tool.

SPL Conversion Services

Navitas pharmaREADY SPL Center has extensive experience in converting and creating thousands of labeling XML files which were fully compliant with SPL guidelines and accepted by FDA.

The Navitas pharmaREADY SPL team has helped companies convert their existing SPL R3 files to SPL R4 and get compliant even before the June 2009 FDA mandate.

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