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…”
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 Transformation
Convert your documents and valuable content into future-proof formats like PDF & PDF/A for archival purposes.
Unlock Unstructured Data
Your data in unstructured file formats? Transform them easily into workable formats for AI, IDMP or other purposes.
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.
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 a unique ability to save & configure reusable workflows. The obligation to reconfigure the tools every single time to different 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 frequently needed. DocShifter, with its innovative technology, eliminates this need and can render from any-to-any without the need of having the native application installed on your computer or the server, saving your organization operational costs.
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 solution and can be connected with multiple document management and regulatory information platforms easily. (OpenText Documentum, Veeva, Box, Alfresco, Generis, 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?
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.
Paul Ireland – VP Life Sciences
DocShifter is a highly scalable document transformation solution with an intuitive drag & drop interface that performs any-to-any and any-to-PDF transformation for Life Sciences. These transformation capabilities include but are not limited to: images, videos, pdfs, unstructured data. Understanding your regulatory submission and other regulatory content challenges, DocShifter solution brings innovative approaches with advanced document rendering, email processing for correspondence tracking, unlocking unstructured data by content transformation.
Our goal at DocShifter is to ensure the sustainability of your documents by advanced document rendering & document transformation and document enrichment.
DocShifter for Life-Sciences for Pharmaceutical, Biotechnology and Medical Devices Manufacturers provides advanced rendering software (hi-fi rendering) that creates compliant, submission ready output for regulatory bodies all over the world such as PMDA, EMA, FDA. Correspondence tracking (correspondence management) to track any incoming communication and route it to appropriate directories and repositories is also a functionality. Automate the creation of forms. Lower total costs by optimizing your infrastructure and licencing fees. Secure your eCTD & other electronic submissions with DocShifter. Regulatory Information Management (RIM), Regulatory Operations and Regulatory Strategies Software, also known as Submission Publishing Software. Save time, resources and focus on your core work. Transform to high quality, compliant, submission ready PDF’s with DocShifter. Advanced document rendering for Life Sciences. Fast, easy, automated.
