How CROs & Regulatory Service Providers save time in preparing compliant PDFs
with 3-click automation

Search Results for:

The Importance of File Format Preservation in the context of Archiving

The Importance of File Format Preservation in the context of Archiving

File Format Preservation: What is it?  File format preservation refers to the act of maintaining the integrity and accessibility of digital files over time. It involves ensuring that electronic files can be read and understood by both current and future computer systems, even as technology evolves. The goal of file format preservation is to ensure

The Importance of File Format Preservation in the context of Archiving Read More »

4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them)

For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry as well as medical device knowledge. We interviewed him on 4 situations you have probably faced yourself in regulatory operations, and practical tips to overcome them. Enjoy the read! Challenges and

4 Situations You Probably Faced in Regulatory Operations (and practical tips to overcome them) Read More »

Regulatory Professionals Community on LinkedIn

Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community. Tips & tricks for regulatory submissions, eCTD 4.0 and many more. Join our free Accelerating eCTD submissions LinkedIn newsletter to receive monthly tips and tricks. So far, we have published: Are there any specific topics you would like to read

Regulatory Professionals Community on LinkedIn Read More »

eCTD 4.0: Key Changes & Impact on Submission Content Preparation

Following our previous “What’s next after eCTD?” article, this paper aims to provide a brief update on the next major version of eCTD, version 4.0. Since 2003, eCTD has been adopted by an increasing number of Health Authorities around the world. The standard has evolved incrementally in that time. eCTD 4.0 will introduce significant updates

eCTD 4.0: Key Changes & Impact on Submission Content Preparation Read More »

Creating the right environment for structured and unstructured data to co-exist

There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such as IDMP and EMA’s Digital Application Dataset Integration Project (DADI) or further back, FDA’s Structured Product Labeling, there are good examples of health authorities getting at least some information into

Creating the right environment for structured and unstructured data to co-exist Read More »

A Case Study in Regulatory Operations: Digital Transformation of the Workforce

If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or migrating to cloud-based solutions, testing and implementing automation of repetitive and manual tasks, and preparing for IDMP, CTR and data submissions in general, it probably feels like change is everywhere

A Case Study in Regulatory Operations: Digital Transformation of the Workforce Read More »

What is document rendering, and what can document rendering mean for your business?

What is Document Rendering, and what can it mean for your business?

Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more than just converting from one format to PDF? We will explain what additional functionality document rendering can bring to your business. Many elements can be added to PDF documents to

What is Document Rendering, and what can it mean for your business? Read More »

What is PDF/A, and how to use the PDF/A file format for digital archiving?

What is the PDF/A format, and how to use the PDF/A format for your Digital Archive

Many of us in business and IT set up and maintain digital archives. Banks, insurance, and healthcare or other regulated industries carry a heavy backlog of archival information going back months or years for thousands of clients.  The Bank of England has a public archive of their work, citing more than 96,000 records just on

What is the PDF/A format, and how to use the PDF/A format for your Digital Archive Read More »