December 22, 2020Creating compliant submission-ready PDFs for inclusion in dossiers has proven to be time-consuming, expensive and complex. In this session we share how your peers use modern rendering technology to speed up, reduce the cost of and simplify this process. Our special thanks to the Lorenz team for having us at their Lorenz Connect […]
May 26, 2021Are you getting ready for your next submission? And interested to simplify and speed up submission content creation? Manipulating and finalizing PDFs using desktop tools is a manual task: embedding fonts, checking hyperlinks, adding ToCs and making sure they comply with HA requirements. And repeating this for 100.000s of documents. All this manual
Generate compliant PDFs for multiple HAs automatically BEFORE publishing eCTD leafs Read More »
Wednesday, 20 October 2021You want to make sure that Microsoft Word & PDF documents meet compliance guidelines. And that they are fixed automatically if they don’t. By watching the recording, you learn more about:
How to auto check and fix Word and PDF documents for compliance Read More »
21 April 2022, Thursday, between 17:00 – 17:30 CETRegulatory submissions are one of the most critical milestones for Life Sciences organizations and can consist of thousands of documents. Submitting on time and in full compliance with Regulatory Agencies’ requirements remains a challenge for many companies. Today, many Life Sciences companies still struggle with their submission
June 9, 2022 (Thursday) 17:00 -17:30 PM CETAre you creating your reports manually today? Or perhaps using complex submission publishing tools to build your reports? Investigational medicinal product dossiers (IMPD), clinical study reports (CSR), annual reports, training manuals, standard operating procedures (SOP) and even full 510k & PMA submissions could all benefit from a tool
How to save time and reduce risk by fully automating the creation of your reports Read More »
Thu, Jul 14, 2022, 3:00 PM – 3:30 PM CET Do you need to convert thousands of incoming emails and attachments to a standardized format such as PDF(/A) ? Manually tracking and processing emails, saving the message and attachments to PDF is a very time-consuming and expensive process. Today, this does not have to be
How to automate the conversion of incoming emails? Practical examples. Read More »
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 »
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 »
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 »
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of compliant, submission-ready PDF documents for their 1000’s of clients worldwide. PharmaLex’s services include document pre-publishing and regulatory submission publishing, therefore managing large numbers of documents in different formats and differing
15 years of experience in automating, simplifying and speeding up document conversion. For all regulated industries. Rated 5 stars on Gartner’s Capterra platform.
