Predefined PDF Configurations for FDA, EMA and PMDA

Save time and reduce the risk of technical non-compliance.

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.

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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.

Requires a detailed understanding of the technical specifications of each region.
Time consuming.
Introduces risks.

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

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

Reduces cost of implementing and maintaining the solution

Increases speed of creating compliant submission ready renditions of the same content for multiple authorities

Facilitates the goal of simultaneous global submissions

Demonstrates DocShifter’s continued commitment to supporting Life Sciences organisations

We happily serve | DocShifter | Automating high volume document conversion in Life Sciences and beyond.

Paul Ireland – VP Life Sciences

Looking for a solution that improves your efficiency in document preparation processes?

DocShifter compliant PDF configurations drastically reduce the risk of non-compliance. 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.

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