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eCTD – Webinar (Q1 2021 Webinar)

Are you still checking Word documents and
validating PDFs manually
for eCTD submissions?

This has many disadvantages:

  • Compliance risks

  • Time-consuming

  • Expensive

  • Complex

  • Requires detailed understanding of the technical specification of each region

Learn how auto check + fix of Word & PDF documents for compliance saves you time

Free 30-min webinar

Keywords:

Microsoft Word, Word formatting and styling, errors in Word, PDF, PDF validation, regulatory compliance, faster time-to-market, regulatory submissions, FDA compliance, eCTD submissions, eCTD 4.0

You want to make sure that Word & PDF documents meet compliance guidelines for global eCTD submissions. And that they are fixed automatically if they don’t.

In this 30-minute webinar, Paul Ireland is going to talk about how you can easily:

  •  Automate the formatting checks and fixes of your Microsoft Word documents for compliance (both regulatory and corporate compliance)
  • Automate the validation of PDF files against Health Authority guidelines for your global regulatory submissions
  • Incorporate the Word and PDF checks and fixes into your rendering process
  • Save valuable time and reduce the risk of non-compliance in your global submissions

Who Should Attend?

Regulatory and document management professionals looking to simplify and speed up their eCTD submission content preparation

After attending this webinar, you will learn:

  • How automated Word and PDF checks and fixes save time during your global eCTD submissions
  • How your peers utilize automated Word and PDF check and fix technologies to get to market faster
  • How reducing risk of non-compliance can be achieved by implementing small steps in your existing eCTD submission process

Feb 24, 2021 05:00 PM ECT

We look forward to seeing you in the webinar on February 24th.

Save your spot

About the speaker

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.

Novartis
Bayer
Otsuka pharmaceuticals
Sanofi
Biogen
Chiesi Pharmaceuticals
Debiopharm
Galapagos Biotech
Santander
Preyer IT consulting
Peoplescout Technology
BuyWay
P&V Verzekeringen
Federale verzekering
Turkish Aerospace
Fidea verzekeringen

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.

eCTD adoption status

ectd submissions, regulatory submissions map - which countries are still submitting on paper, and which electronically? | DocShifter

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.