Reduce risk of non-compliance
with our pre-defined
compliant PDF configurations
for any health authority
Manual configuration of tools introduces risks.
Reduce risk of 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 for each region separately. This 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.
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.
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.
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.
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