Reduce risk of non-compliance
with our pre-defined
compliant PDF configurations
for any health authority

Compliant PDF configurations to reduce risk of non-compliance in your submission process | DocShifter

Compliant PDF problems with manual, risky methods

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 for each region separately. This introduces risks and requires a detailed understanding of the technical specifications for each region.

DocShifter's compliant PDF configurations

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.

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.

regional requirements by FDA, PMDA for PDF submissions | DocShifter's compliant PDF configurations save time and reduce risk of non-compliance

Reduce risk of technical non-compliance with DocShifter's compliant PDF configurations for FDA, EMa, PMDA and any other health authority.

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.
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.

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.
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

What are the FDA PDF format specifications?

Many different formats go into a submission package: Word, Excel, PowerPoint, text files, image files and many more. All these formats must be formatted in a specific way to become FDA compliant.

We have prepared this free FDA PDF format specifications checklist to make sure that your PDF content fully complies with FDA guidelines.

Download the checklist

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.