allianceofexperts.com

eCTD – Solutions

Are you still manually editing PDFs
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

Upcoming Webinars – Open for Registration

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 for global eCTD submissions can be fully automated.

DocShifter software creates fully compliant PDFs for all your eCTD submissions from the source documents, no matter where your content resides (RIM, eDMS or other)

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

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.

Compliant PDF conversion for
eCTD submission readiness

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

Automated PDF Validator – Fixer

Pre-defined, compliant PDF configurations for FDA, EMA, PMDA, HC and other health authorities. Complaint, submission-ready PDF.

Compliant PDF configurations
for eCTD submissions

Frequently Asked Questions

What is DocShifter?

DocShifter is the world’s fastest any-to-PDF converter. This is why many small and large companies choose 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 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 info@docshifter.com

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.

eCTD adoption status

ectd map - which countries are still submitting on paper, and which electronically? | DocShifter
Paul Ireland - VP Life Sciences - DocShifter

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.

Would you like me to contact you?
Let me know how I can help.

[]
1 Step 1
reCaptcha v3
keyboard_arrow_leftPrevious
Nextkeyboard_arrow_right