eCTD – Solutions

Are you still
manually checking and fixing
Word and PDF documents
for eCTD submissions?

This has many disadvantages:

  • Compliance risks

  • Time-consuming

  • Expensive

  • Complex

  • Requires detailed understanding of the technical specification of each region

Save time and reduce risk of non-compliance with our automated PDF solutions

Make sure that all your PDFs are already compliant
for eCTD submissions
before publishing stage

Ensuring technical PDF compliance for eCTD submissions is complex and very time-consuming.
A lot of companies still manually manipulate PDFs to prepare for FDA, EMA, PMDA, HC, SwissHealth and other health authorities.
Manual work introduces compliance risks.

Compliant PDF creation, automatically checking and fixing Word and PDF documents
for global eCTD submissions can be fully automated.

DocShifter software checks and fixes Word documents, creates fully compliant PDFs and validates them for all your eCTD submissions
no matter where your content resides (RIM, eDMS or other)

This reduces manual work, risk of non-compliance and speeds up time to market.

Improve document lifecycle and start validating PDFs earlier in your regulatory content preparation process with DocShifter's automated PDF validation software

Save time and reduce risk in your eCTD submissions
through automation

Submission-ready PDF conversion software for Life Sciences & Pharma. Create submission ready, compliant PDF for FDA, EMA, PMDA, HC and many more.

Submission-ready, compliant PDF

The easiest way to automatically create submission-ready PDF renditions for multiple health authorities
for eCTD submission readiness. 

word formatting checker | Automatically identify and fix errors in your Word documents before you render them to PDFs. Software solution for medical writers and regulatory operations to reduce risk of non-compliance.

Automatically check and fix Word

Automatically check Word documents for regulatory and corporate compliance, and fix errors. Speed up document preparation and reduce risk of non-compliance. 

Automatically validate PDF against FDA, PMDA, EMA and many more for your regulatory submissions

Automatically validate PDF

Automatically validate every PDF that goes into your eCTD submission package. Provide submission ready documents to your publishers quicker than ever.

Otsuka pharmaceuticals
Chiesi Pharmaceuticals
Galapagos Biotech
Preyer IT consulting
Peoplescout Technology
P&V Verzekeringen
Federale verzekering
Turkish Aerospace
Fidea verzekeringen

Simplify and automate the generation of
submission ready PDF renditions
for global submissions

Submission-ready PDF conversion software for regulatory submissions for Life Sciences & Pharma. Create submission ready, compliant PDF for FDA, EMA, PMDA, HC and many more.

Frequently Asked Questions

What is DocShifter?

DocShifter is the world’s fastest any-to-PDF converter. This is why many small and large companies use our software to automatically create technically compliant, submission-ready PDF.

High volume, high quality document conversion, on premises or in the cloud. Super easy to set up. Automate. Centralize. Eliminate manual intervention. Reduce Risk. Reduce IT infrastructure costs.

Who is using DocShifter today?

DocShifter is being used by many small and large pharma, biotech, medical device and contract research (CRO) companies.

How does DocShifter speed up the creation of submission-ready PDFs?

DocShifter can use the same source document to generate compliant output to different health authorities simultaneously: FDA, PMDA, EMA, HC, SwissHealth and many more. Because DocShifter does not use any native application such as MS Office, or any Adobe technology, it is able to convert documents significantly more quickly than legacy methods. 

Submission-ready PDF conversion software for regulatory submissions for Life Sciences & Pharma. Create submission ready, compliant PDF for FDA, EMA, PMDA, HC and many more.

Which systems can DocShifter connect to?

DocShifter has native integrations with OpenText Documentum, Veeva Vault, Microsoft SharePoint Cloud, Generis CARA, Lorenz Docubridge, File Systems, Dropbox and FTP.

It also supports any other system that allows Web Services API connections, such as IBM Filenet, Box, Alfresco etc.

Can I deploy DocShifter in a cloud environment?

DocShifter can be deployed anywhere: in a private, hybrid or public cloud. Furthermore, deploying DocShifter on Docker/Kubernetes allows for infinite scalability to handle peak loads. 

How about pricing?

DocShifter subscription pricing is server, volume and functionality based. To find out more about pricing, please drop us a note at

Is DocShifter an eCTD publishing tool?

No, DocShifter is not an eCTD publishing tool. Our software helps you create compliant PDFs. The PDFs are ready to be used in your global submissions.

Compiling the PDFs and structuring them according to eCTD guidelines is not handled by DocShifter.

The impact of automation on your operations

eCTD adoption status

ectd submissions, regulatory submissions map - which countries are still submitting on paper, and which electronically? | DocShifter
DocShifter team - the world's fastest document conversion sofftware - Schedule a live demo or contact us.

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