Too many regulations,
too little time.
Time to market is key for any Life Sciences company. The patients' health is at stake.
Few industries face the same level of regulatory complexity. Tight timelines and different compliance requirements across the globe require strict processes and tools to support them. The right technology is fundamental in ensuring success.
EMA, FDA, PMDA, etc. have their own needs.
Each global regulator has similar but slightly different requirements for the content that is shared with them.
Ensuring that your content meets the technical requirements of each health authority is time consuming and introduces risks. The same content can be used in multiple submissions, but the PDF might need to include different elements for each (bookmark levels and structure, PDF version used, etc.).
Automating the PDF preparation process to ensure the appropriate rules are used is critical.
Manually manipulating PDFs is risky.
Ensure your PDF content is submission-ready using desktop tools is a manual, time-consuming task. Embedding fonts, checking hyperlinks, adding ToCs, setting the appropriate zoom-level on all links and bookmarks, etc. To make sure they comply with HA requirements.
Repeating this manually for thousands of documents introduces serious risk of non-compliance and delays to your timelines.
Generate compliant PDF renditions for multiple Health Authorities simultaneously.
DocShifter is a document to PDF conversion software for the entire enterprise. It takes all your source files (MS Office files, e-mail and attachments, scanned images, audio, video, etc.), from wherever they are stored, automatically converts them to PDF and enriches the output to meet specific Health Authority requirements.
DocShifter can also generate multiple submission-ready renditions for multiple Health authorities (FDA, EMA, PMDA, HC, SwissHealth, etc.) in one go, first checking the input document for issues and fixing many common problems it finds. Once converted, it can also perform validation checks and generate a report to further reduce manual effort.
Simplify and speed up submission content preparation.
Create what the regulators demand: navigation-rich, searchable PDF renditions.
Each region has guidance for many elements of the PDFs that need to be supplied: rules for fonts used and how they should be embedded, image compression, bookmarks inclusion, hyperlink usage, security, initial page view options, general formatting and much more.
Having a submission rejected by a health authority because your PDFs don’t meet their technical requirements is financially expensive, and negatively affects the company’s image.
DocShifter automatically generates ICH & eCTD compliant PDF renditions from your source documents. The output fully complies with the stringent rules laid out.
Extensive PDF enrichment options.
DocShifter has extensive PDF options for you to fully comply with the complex health authority requirements.
These options include but are not limited to: hyperlink and bookmark management to meet any standard, zoom levels, PDF version options, initial page view settings, track changes handling, OCR for scanned content, font embedding and substitution management and many more.
Free FDA PDF format specifications checklist
To help you out in your submissions to US FDA, we prepared a free checklist. This free FDA PDF specifications checklist can help you reduce risk of non-compliance in your submission content preparation for FDA.
A centralized PDF conversion software for your enterprise.
DocShifter is the world’s fastest fully-automated any-to-PDF conversion software. Designed for high-volumes, DocShifter is able to connect to your existing content systems, create searchable, navigation-rich PDF renditions from your documents and store these in the systems of your choice.
With DocShifter, you can fully automate time-consuming manual document conversion processes, reduce costs, strengthen control and assure compliance.
Are you looking for a highly scalable, fully-automated any-to-PDF converter? Give DocShifter a try; you will see why leading pharmaceutical and biotechnology companies rely on DocShifter to prepare their submission-ready PDFs.
PDF enrichment features to accelerate your submission content preparation.
Reduce the risk of non-compliance by centralizing submission-ready PDF conversion.
Frequently Asked Questions.
Yes to both questions. DocShifter can automatically create bookmarks in many different ways. DocShifter can create bookmarks from custom heading styles, as well as from Word’s default headings.
For Table of Contents (ToC), you can define whether you would like to create it at Word level, or PDF level. You can set limits, and skip generating a ToC if the page contains less than 5 pages, for example. You can also automatically define rules to automatically create a ToC if the page exceeds 10 pages.
For more questions, please drop us a note.
No, DocShifter is not an eCTD publishing tool. Our software helps you create compliant PDFs. These 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.
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.
Yes of course. We thought you were never going to ask.
There are multiple options:
- Hand-held demos with your own content.
- A dedicated environment that you can use to upload files to. Where you can configure your own workflows.
- On-premise trial installations, so you can test quality and performance within your own infrastructure.
DocShifter can handle more than 300 input formats. These input file formats include but are not limited to: Microsoft Office and text file formats (such as DOC, DOT, DOCM, DOCX, DOTX, RTF, HTML, TXT etc.), mark-up file formats (such as HTML, XML, CSS, XSL, XSLT etc.), PDF formats (PDF, ODFA etc.), compressed file formats (.tar, .gz, ZIP file with text files, ZIP file with on PDF, Microsoft Offices etc.), image file formats (JPEG, BMP, PNG, GIF, TIFF, RAW, PSD, DXG and DWG etc.).
For an extensive list, please contact us with your questions.
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.
DocShifter subscription pricing is server, volume and functionality based.
To find out more about pricing, please visit our Pricing page and request a quote.
DocShifter is the world’s fastest any to any conversion software. Speed, quality, scalability and configurability are the reasons why leading companies use our software to convert their documents into high quality, navigation-rich, searchable content.
Let us handle the hard stuff
You know your business better than anyone else. That's why we're here to take care of the hard stuff. You can trust us with all your conversion needs, from installation, configuration, to testing and production. We're experts in conversion services and have been for 15 years.
Compliant, fast, automated and scalable
file format conversion for the regulated enterprise.
PharmaLex reduces manual work, and the associated costs & risks to accelerate compliant PDF conversion of submission content
“DocShifter will save us over 750 hours of manual work per year. And we expect the time savings to increase as we continue to expand our use of DocShifter.
This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently.
“The quality and reliability of DocShifter is very good. The integration with our submission management system makes it seamless to generate submission-ready PDFs, and the volume of PDF features eliminates most of our manual work.”
Jennie May – Director, Regulatory Operations
5 minutes saved per document
PharmaLex saves 5 minutes per document, across thousands of documents they process every month.
With DocShifter, PharmaLex is able to publish eCTD leaflets a lot quicker, while maintaining essential quality and compliance.
Centralizing PDF conversion
PharmaLex was previously using licensed PDF plug-in tools to prepare content for inclusion in submissions. The process of converting the original source documents to fully compliant submission-ready documents was complex, manual and extremely time-consuming.
With DocShifter, PharmaLex is saving time and money while being able to automate most of the dull and repetitive tasks they used to have.
Accelerating submission publishing
Thanks to DocShifter’s wide range of PDF features, PharmaLex’s expert submission-publishing team is able to process more documents in a shorter amount of time.
PharmaLex is no longer manually editing PDFs for submission readiness. Hyperlinks, bookmarks, zoom levels, fonts, table of contents and many other compliance elements are handled automatically by DocShifter.
"They listen, and make it happen. Very quickly."
PharmaLex has had some specific requirements for creating submission-ready PDF renditions.
Due to the architecture, it is very easy to implement changes in DocShifter. We have listened to PharmaLex’s needs and suggestions, and have incorporated them in DocShifter in a short amount of time.
See what our beloved customers have to say about us:
And what really sets it apart from what we were doing before, DocShifter tells us what went wrong, so we can act upon the documents that did not convert".
This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently. "
The product is reliable, extremely fast and produces output that is compliant with multiple Health Authorities."