Submission-ready PDFs for multiple health authorities
Full eCTD compliance without any manual work
Create what the regulators demand: fully searchable, compliant PDF renditions
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.
Speak to a specialist during a personalized demo.
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 can be configured to monitor where you store your submission content: regulatory information management systems, local folders; and based on automated triggers (status change, document update, new document in a monitored location, etc.) it automatically processes the documents.
The way the documents are processed is completely up to the configurations you set. If you are submitting to US FDA, all documents will be rendered to the US FDA PDF specifications; with the correct bookmark settings, inherit zoom options, hyperlinks, table of content at the beginning if your document contains more than 5 pages.
Fully automated.
The same logic applies to any other region you will be submitting to.
Will I be able to generate compliant PDFs for multiple regions?
Yes. DocShifter can be configured for 'single input' --> multiple output.
DocShifter can render the same source documents in your regulatory information management system to US FDA, HealthCanada, PMDA in Japan specifications. Simultaneously. Results will be slightly different based on the parameters set; and fully compliant for the HA you are submitting to.
What are the common submission requirements for PDFs?
In life sciences, common submission requirements for PDFs include adhering to specified PDF versions, ensuring accurate metadata, embedding fonts, structuring for accessibility, validating hyperlinks and bookmarks, implementing security features, following page size and margin guidelines, optimizing image resolution and compression, incorporating functional form fields, supporting digital signatures, and ensuring text searchability. Text searchability is essential for regulatory review, requiring documents to be machine-readable, selectable, copyable, and searchable by text-based queries. Specific requirements vary by regulatory agency, necessitating compliance with agency-specific guidelines such as those provided by the FDA or EMA.
I use other tools as part of my submission process. Can DocShifter integrate with them?
Absolutely. DocShifter seamlessly integrates with every single tool you have in place today, either through native connectors, or through API services.
For more information about connectivity, please visit this page.
Do we use DocShifter as a standalone app that integrates/pull sinformatin from other systems (Veeva, Documentum, etc.), or is it more like an extension/plug-in that we use in our existing programs or environments?
It is a standalone applications that easily integrates with multiple other systems such as Veeva, Documentum, Cara. It’s not a plug in as such to these systems. We like to present ourselves as ‘the Switzerland of advanced rendering’, meaning we sit aside, and can easily be coupled with one or more systems in the organisation.
Can Docshifeter compile documents along with appendices and then create table of contents for merged (complied) file in the output?
Yes. You can find more information on this on our automated report publishing page.
Does DocShifter integrate with other tools? e.g. Integrate with Veeva/Cara so we can keep everything in one place (collaborative authoring) or is it a separate tool (standalone)?
It integrates with most tools such as Veeva and Cara - where the documents are stored. DocShifter works alongside and connects to all these systems, uses the metadata that is available in those tools.
Connecting with the document management system. How the rendering process in DocShifter triggered when the document is in the document management system? For example, is it possible to start rendering when the document's status is changed to final in the document management system? And also is it possible to put the rendered PDF back to the document management system automatically?
Based on the DMS you use, there are different triggers available. You can do that completely automated, or use some sort of manual 'I want this document to be rendered right now' process.
In SharePoint, Paul talks about column updates or metadata triggers, but in Veeva, it could be lifecycle update, metadata, or simply monitoring certain document types, for example.
And yes, DocShifter automatically writes the rendered PDF back to your DMS.
