Supporting every step of your
submission content preparation.
Solving your compliant
content preparation challenges.
Submission ready PDF
Create searchable, navigation-rich, compliant PDF documents for your regulators all around the world.
Automated Word checker and fixer
Automatically check and fix Microsoft Word documents for styling and formatting errors.
Automated PDF validation
Check and fix your PDFs to make sure they comply with internal and external guidelines
PDF/A & TIFF conversion for archiving
Mass convert all your enterprise files to future proof file formats such as PDF/A or TIFF.
Incoming e-mail conversion
Monitor e-mail inboxes and automatically convert e-mail and attachments to PDF or other formats.
Audio and video conversion
Automatically convert audio and video files to the format of your choice.
1 software solution to go from source documents to creating and validating compliant PDF documents for multiple HAs
DocShifter automatically recognizes documents, emails, images, audio, and video files and converts them to the output format and specification required. In fully submission-ready, technically-compliant PDF or any other standardized format. Lightning fast. Once converted, these documents can be stored in a controlled Document Management System and included in any dossier needed, or archived as PDF/A.
DocShifter can also convert individual documents into multiple output files, meeting the specifications of each regulator needed in one go, first checking the input document for issues and fixing many common problems it finds. Once converted, it can even automatically check and generate reports to demonstrate the converted files meet the requirements set out by each of the health authorities.
Output can be enriched in many ways. OCR, automated table of content creation, headers and footers, bookmarks, watermarks and many more.
Centralize. Automate. Reduce risks.
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.
"How does document conversion impact regulatory operations?"
“We have documentation in different languages, but when converting everything to PDF for submissions, things got complicated really fast. Our rendition engine couldn’t cope with all those fonts, and we lost a lot of time fixing problems that weren’t supposed to be there in the first place.
We decided to make a switch to DocShifter.
Scalability during our peak times, ability to deal with multiple fonts, automation (conversion of source documents to simultaneous submission-ready PDFs for multiple health authorities) and performance.
These are just some of the things that make DocShifter such a powerful rendering engine.”