Advanced Rendering & Document Enhancement for Life Sciences

Easily render your documents to submission ready PDF formats for health authorities anywhere in the world like FDA, EMA, PMDA and more.
Generate standard forms, reports, statements (Application Forms, CRF’s) automatically and eliminate human error.
Your data in unstructured file formats? Transform them easily into workable formats for AI, IDMP or other purposes.

Regulatory Content Challenges

Creating Submission-ready PDFs is complex

“Creating compliant submission ready output for each region is complex, expensive and time-consuming. We also have to re-configure our tools every time for different regulatory health authorities…”

Regulatory Correspondence Is Difficult to Trace

“Thousands of conversations with external bodies need to be identified, converted & stored in appropriate repositories… Current process is slow, manual and prone to human error. This introduces delays. ”

Archived Formats are Not Future Proof

“Huge quantities of documents and other content (video, forms, audio) need to be prepared for storage in an archive…”

Unstructured Content is Inaccessible for AI & IDMP

“Huge quantities of information is locked up in unstructured formats and we can’t use these for Artificial Intelligence or IDMP purposes…”

Non-Compliant Output is a real risk

“With any manual step in the process, an element of risk is introduced. This can cause delay and rework…”

Forms are Generated Manually

“Many forms and other repetitive documents (CRFs, Application Forms, etc.) needs to be generated manually…”

Advanced Rendering & Document Enhancement Made Easy

Compliant Rendering
to Local Agency Requirements

Easily render your documents to submission ready PDF formats for health authorities anywhere in the world like FDA, EMA, PMDA and more.

Email Processing
for Correspondence Tracking

Easily monitor, identify, convert and store the conversations with external bodies in appropriate repositories.

Digital Archiving - Convert documents to PDF, PDF/A, TIFF or other archiving formats for accessibility in the future

Digital Archiving Transformation

Convert your documents and valuable content into future-proof formats like PDF & PDF/A for archival purposes.

Mail Converter - Convert emails, scanned images and other attachments to the required format. Automatically recognize incoming file formats. Easily send these to your document management or tracking systems.

Unlock Unstructured Data

Your data in unstructured file formats? Transform them easily into workable formats for AI, IDMP or other purposes.

Submission Ready PDF - Create Compliant PDF's for your regulatory submission. EMA, PMDA, FDA and other regulatory bodies.

Advanced Rendering

Specify PDF version for output, apply complex bookmarking, gain control over the style of some output elements (bookmarks, hyperlinks), specify font embedding usage, add & remove security options and perform much more with Advanced Rendering.

Automated Document Generation

Generate standard forms, reports, statements (Application Forms, CRF’s) automatically and eliminate human error.

We Happily Serve

Technical Capabilities of DocShifter

Submission ready PDF rendition

Compliance with the standards (ICH, ISO, eCTD, NeeS) of the regulatory bodies (EMA, FDA, PMDA) is a must for Life Sciences. With DocShifter you can easily set up your different output configurations, adapted to the local requirements. Reducing the risk of non-compliance and speeding up the process.

Extensive Document Enhancement

With DocShifter, easily perform document enhancement to high volume of documents. These include but are not limited to: PDF merging, specifying PDF output, font embedding, PDF enrichment, splitting, pagination, adding watermarks, header & footer, advanced bookmarking, adding & removing security, adding thumbnails.

Understanding Local Submission Requirements

With DocShifter, you can specify the output to comply with the local regulatory authorities. You can create PDF to correct compliant version (1.4 – 1.7 or PDF/A) depending on the region, control region specific features (opening bookmarks to specific level only for clean initial view for Japan or grouping bookmarks to ease navigations for Japan) or optimize output for fast web viewing. DocShifter also fully supports double-byte content.

Intuitive Drag & Drop Interface

With the intuitive, web-based drag & drop interface, DocShifter offers unique abilities to save & configure reusable workflows. The obligation to reconfigure the tools every single time to the specification of health authorities, is no more needed.

Native Applications Not Needed

While rendering from one format to another, native applications that can read & open the source format are required. DocShifter, with its innovative technology, eliminates this need and can render from any-to-any without having the native application(s) installed on your computer or the server, saving your organization operational costs and time.

Easily Transform +300 Formats

Transform content and metadata to PDF, DOC(X), ODT, HTML, RTF, TXT or one of the other supported formats depending on the input format. Generate the same document into multiple formats.

Platform Independent & Easy to Integrate

DocShifter is a cloud ready, platform independent (e.g Microsoft, Linux) solution and can easily be connected with multiple document management and regulatory information platforms. (OpenText Documentum, Veeva, Box, Alfresco, Generis CARA, Microsoft Sharepoint e.g) The open API / REST services allow the integration and connection with platforms that are supported out of the box.

The DocShifter solution is also ready to run in containers.

Why switch to DocShifter today?

DocShifter vs. Other Rendering Solutions |

Paul Ireland – VP Life Sciences

Let’s talk about a solution that improves your efficiency & speeds up the document transformation process

Are you looking for a solution to create compliant output for regulatory health authorities?

Are you looking for a solution to process & standardize your communication for correspondence tracking?

Are you looking for a reliable solution for all your content transformation and advanced rendering requests?

We have your solution.

Try DocShifter