Submission-ready PDFs for multiple health authorities
Full eCTD compliance without any manual work
Create what the regulators demand: fully searchable, compliant PDF renditions
5 starts based on 8 reviews on Gartner's Capterra platform
Benefit from a confidently compliant submission-ready PDF solution
Automated validation across multiple regions
Compatible with all regions, including USA, Europe, GCC, Japan and more
One solution for multiple compliant PDF renditions
Avoid multiple siloed desktop tools and sync everything into one solution
Reduce time to market
Save time and money with one-and-done setup and automations
100% Risk Reduction
Pre-configured PDF compliance settings for all Health Authorities
Avoid Refusal to File
Automated generation of high-quality, uniform and compliant PDF outputs
The Solution: Fully-compliant submission-ready PDFs with DocShifter
DocShifter is a document-to-PDF conversion software with compliance at its core, generating submission-ready renditions for multiple health authorities. Including:
- US FDA
- Health Canada
- MHRA in UK
- PMDA in Japan
- SwissMedic in Switzerland
- CFDA in China
- Thiland
- Australia
- and any other HA
Convert all source files into submission-ready PDFs. Hundreds of configuration options ensure your PDFs meet the most demanding of HA requirements.
Our goal? To facilitate an easy submission. Whether you submit to 1 or more health authorities. Without the human intervention.
See how we make your PDFs submission ready
Automatically make your PDFs submission-ready.
Thanks to hundreds of PDF configuration options.
- Authors store their documents as usual. A DocShifter workflow will pick up the document automatically and convert to the right format, at the right time
- Workflows automatically route content based on the type of file, metadata, template used, signed or not signed documents, and much more
- Simple to use and highly flexible workflows to define your automation steps
- Check for new documents from multiple content sources (see DS Connectors to find out more)
- Automatically reject conversion tasks with specific characteristics
- Automatically notify people of conversion errors
- Advanced image handling within documents (dpi, encoding, quality, etc.)
- Advanced image and email format conversions (sizing, orientation, aspect ratio, scaling, and more)
- Advanced Word, Excel, PowerPoint, email, text and image format handling
- Ensure tracked changes convert consistently
- Field code handling to ensure content is up-to-date
- Process or exclude embedded files (including zip, docx, and more)
- Generate bookmarks from any styles, including your own custom styles
- Ensure hyperlinks are consistently formatted and styled
- Set magnification and zoom level for bookmarks and hyperlinks
- Automatically create bookmarks for PDFs that have no bookmarks (based on text font, size, and more)
- Convert from various input formats to PDF or PDF/A
- Select the PDF or PDF/A version of your choice
- Set PDF properties and leverage any DMS metadata
- Flatten PDFs where needed
- Optimize PDF (including for fast web view)
- Ensure PDF viewing preferences are set correctly
- Embed fonts as required (all, subset, nonstandard, and more)
- Automatic font substitutions where fonts are unavailable
- Force specific font substitutions to use available fonts
- Embed attachments
- Fit Excel sheet to a PDF page
- Define the Excel paper size for rendering
- Only render selected sheets in an Excel file to PDF
- And many more
- PDF branding features including watermarks, headers and footers, numbers and many more
Do you recognize these challenges?
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 specific technical PDF requirements
Each global regulator has similar, but slightly different requirements. While the same content can be reused, the final PDF needs to be different (e.g. bookmark levels set, PDF version, etc.). Automating this PDF preparation process to ensure the right requirements are used is critical. You do not want to do this manually.
Using multiple tools is expensive
From submission content preparation to eCTD submissions, many organizations still rely on multiple, siloed desktop tools (such as MS Office and Adobe technology) – causing high IT infrastructure and licensing costs. By syncing into a single solution, companies can avoid time-to-market delays and stem financial losses.
Manually manipulating PDFs is risky
Using desktop tools to manually handle PDF content is an error-prone task. Embedding fonts, checking hyperlinks, adding ToCs and setting zoom-levels on links and bookmarks to ensure health authority compliance all too often becomes time-consuming. Get it wrong, however, and it can cost a lot more than just your time.
Trusted by life sciences companies of all sizes
See how Pharmalex ensures their PDFs are submission ready using DocShifter
PharmaLex, a technology-enabled solution provider in the Life Sciences industry, partnered with DocShifter to streamline their complex PDF-submission process for their 1000+ clients worldwide. So what changed?
Speak to one of our specialists
Frequently Asked Questions
How Does DocShifter help me create submission-ready PDFs?
DocShifter works with Linux, Windows, Docker/Kubernetes; 32GB RAM, 50GB storage, JAva JRE or JDK, and Visual C++ Redistributable for Visual Studio. Please contact us here to talk to us about more specific details for your environment.
Will I be able to generate compliant PDFs for multiple regions?
From scaling content to fit the defined page size, automatically setting the page size based on the content – and even converting each sheet to a single PDF page – there are multiple options available when handling Excel files in DocShifter.
What are the common submission requirements for PDFs?
Absolutely. DocShifter can recognize if a PDF file is signed and process it differently from non-signed content. PDfs can be flattened if required, and original signed PDFs can be attached to converted PDF files to retain any of the original signatures.
What if changes in eCTD regulatory requirements occur?
DocShifter allows for fully-automated OCR from any file format supported, which includes all image formats listed in a given RFP. The accuracy of results will depend on the quality of the image being processed via OCR, so the required 90% guarantee cannot be achieved without the quality of the content source also being guaranteed.
I use other tools as part of my submission process. Can DocShifter integrate with them?
DocShifter’s software can be deployed on-premise or in your cloud (AWS/Azure/Google). On Microsoft Windows or Linux. Either directly onto hardware, using VMWare or in a Docker / Kubernetes infrastructure.
