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…”
Your Regulatory Content Challenges
Our Solutions
Compliant Rendering to Local Agency Requirements
Easily render your documents to technically compliant, submission ready PDF formats for health authorities anywhere in the world like FDA, EMA, PMDA and more.
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. ”
Email Processing for Correspondence Tracking
Easily monitor, identify, convert and store the conversations with external bodies in appropriate repositories.
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…”
File Format Transformation for Digital Archiving
Convert your documents and valuable content into future-proof formats like PDF & PDF/A for archival purposes.
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…”
Unlock Unstructured Data
Your data in unstructured file formats? Transform them easily into workable formats for AI, IDMP or other purposes.
Forms are Generated Manually
“Many forms and other repetitive documents (CRFs, Application Forms, etc.) needs to be generated manually…”
Automated Document Generation
Generate standard forms, reports, statements (Application Forms, CRF’s) automatically and eliminate human error.
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…”
Advanced Document Rendering and Enriching
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.
We Happily Serve
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 document transformation and enrichment requests?
We have your solution.
