Navigating the Regulatory Submission Process
Regulatory submissions are a very critical milestone in the life sciences industry. They are literally the translation of (mostly) 10 years’ worth of R&D work into success. Therefore, navigating regulatory submissions is a critical and often complex hurdle. The regulatory submissions process involves 5 main stages, being: Pre-submission Application preparation Submission & review Addressing deficiencies […]
3 Click Compliance: What does it mean? How does it work?
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it. The technology that makes it possible to significantly speed up and simplify the way you prepare content for submissions today. DocShifter Express. What is DocShifter Express (DS Express)? DocShifter Express is a browser-based platform that simplifies and streamlines various […]
Ennov Acquires DocShifter, the Ultimate Document Conversion Software for Regulated Enterprises
Paris, France – February 6, 2024 Ennov, provider of the only cloud-based unified compliance platform for life sciences – a highly configurable software architecture that delivers a consistent user experience and eliminates data silos – is proud to announce today the acquisition of DocShifter, a trusted global leader in document transformation software. With this acquisition, […]
How to automate PDF submission content preparation to speed up publishing
1. Save hundreds of hours every month when preparing PDFs for submission-readiness If regulatory operations teams could have a wish, one would be to have all documents formatted properly, according to the guidelines. Unfortunately, even when external and internal resources work with perfectly-styled Microsoft Word templates, it is no surprise that almost everyone has their […]
The Risks of Manual PDF Manipulation in Life Sciences Compliance (and the benefits of automation)
Introduction Welcome to a journey through the complexities of PDF compliance within the life sciences. This article aims to enlighten you on various critical aspects: Gaining insights into the complex process of manual PDF preparation for compliance. Learning about the numerous challenges and limitations associated with manual PDF manipulation. Discovering how automation revolutionizes submission content […]
Achieving Regulatory Excellence: Must-Have Attributes
In our latest edition of the thought leadership series, we were honored to have Dr. Benita von Glahn (Head Global Regulatory Affairs and member of the R&D Executive Leadership Team) from Merz Therapeutics. With her extensive expertise and remarkable insights about the complex regulatory landscape, Benita shed light on the strategies and must-have attributes crucial to building […]
What is OCR? A Guide on Optical Character Recognition
A Complete Guide to Optical Character Recognition (OCR) In today’s fast-paced world, businesses need practical solutions to tackle everyday challenges efficiently. One such solution is OCR, or Optical Character Recognition. Whether you’re in banking, insurance, or life sciences, OCR has real-world applications that can make your work easier. OCR, or Optical Character Recognition, is a […]
Automation in OpenText Documentum with DocShifter
1. Rendering is more than creating a PDF. No matter which document management system you use. Traditionally, rendering has often been viewed as a straightforward process of converting one file format into another, like turning a Word document into a PDF. Many people simply associate rendering with this basic format conversion, and that’s where it […]
How To Render Veeva Binders With DocShifter: Webinar Key Takeaways
DocShifter offers a powerful solution for automating the rendering of Veeva binders, streamlining the process and ensuring submission-ready PDF reports. Binders are being used by almost all Veeva customers, and we received a question to run a specific webinar on this topic. This was the major focus of the webinar, and here’s how you automate Veeva […]
Compliant file format transformation on Microsoft Azure Marketplace
We are thrilled to announce that DocShifter is now available on the Microsoft Azure Marketplace! For those customers that are seeking to deploy DocShifter in their Azure cloud, the strategic partnership with Microsoft opens up exciting possibilities. Getting started with DocShifter is now only a few clicks away, with DocShifter available as a Virtual Machine […]