Reduced risk and increased compliance for global submissions thanks to pre-defined compliant PDF configurations

Life Sciences organizations must follow the detailed specifications of each region for electronic submissions. The tools that create compliant submission ready documents need to be configured, which introduces risks and requires a detailed understanding of the technical specifications for each region.

DocShifter supplies standard PDF configurations for each region that accepts eCTD submissions. When these PDF configurations are used, the output will be fully technically compliant to the requirements of the desired health authority, such as FDA, PMDA, EMA, HC and many more.

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The Challenge

Each region that accepts electronic submissions mandates the format and detailed specification of those formats for Life Sciences organisations to follow. These organisations have to convert multiple electronic formats to meet these standards. Large amounts of the content shared with health authorities is also reused when submitting applications in other regions.

Even tools that can create compliant submission ready documents need to be manually configured and maintained.

Manual configuration of tools introduces risks.
Manual configuration of tools for each region is very costly and time consuming.
Requires a detailed understanding of the technical specifications of each region.

Some of the regional requirements by FDA, PMDA and other health authorities
Regional Requirements	FDA	PMDA	Other Regions
PDF/A-1, PDF/A-2 are accepted.	✅	❌	❌
Optimized for fast web viewing	✅	✅	✅
Bookmarks should be open to a specific level	❌	✅	❌

The Solution

DocShifter supplies standard PDF configurations for each region that accepts eCTD submissions. When these PDF configurations are used, the output will be fully technically compliant to the requirements of the desired health authority, such as FDA, PMDA, EMA, HC and many more.

By supplying compliant PDF configurations for each region that accepts eCTD submissions, DocShifter:

Reduces the risk of non-compliance.
Enables renditions to be created for multiple regions simultaneously.

Pre-packed workflow with compliant PDF rendition configurations for each region (FDA, EMA, PMDA and many more).
The configurations provided with the workflow, preset the options required to create fully compliant, submission-ready renditions for each region.
Where the template and configurations are used as provided by DocShifter, the output will be fully technically compliant.

It is possible to create multiple renditions at one time for each region where the content will be submitted, supporting the goal of global simultaneous submissions.
The PDF configurations are flexible where the health authorities allow for a range of options rather than mandating one specific value (e.g. PDF version 1.4, 1.5, 1.6 or 1.7) can be used in most regions.
Reduces the time needed to implement the rendering solution.

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The Impact

The compliant PDF configurations provided with the DocShifter workflows, preset the options required to create fully compliant, submission-ready renditions for each region. This reduces the time needed to implement the rendering solution, saving organizations time and money.

Removes the risk of technical non-compliance
Facilitates the goal of simultaneous global submissions
Reduces cost of implementing and maintaining the solution

Increases speed of creating compliant submission ready renditions of the same content for multiple authorities
Demonstrates DocShifter’s continued commitment to supporting Life Sciences organisations

Paul Ireland – VP Life Sciences

20+ years experience in delivering Content Rendering, Regulatory Information Management, Submission and Report-level Publishing, and Electronic Document Management solutions.

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