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A big thank you to Kathie Clark for joining us in our LinkedIn Live session!
With her extensive experience...
Why does AI in Regulatory Content Preparation Matter?
As artificial intelligence technology continues...
510k submission checklist
Get access to all 510(k) submission formatting specifications via our downloadable...
Manual document preparation for compliance can be both time-consuming and error-prone. Regulatory teams...
The electronic Common Technical Document (eCTD) has revolutionized the drug development and approval...
The Role of PDFs in Regulatory Submissions: Navigating Challenges and Ensuring Compliance in the Life...
When we started our international DocShifter journey 6 years ago, our ambition was to improve the way...
PDFs are more than just static documents — they hold a wealth of data that can be crucial for making...
An MAA submission is a comprehensive dossier submitted by a pharmaceutical company to regulatory authorities...
What is a Clinical Trial Application (CTA)?
A Clinical Trial Application (CTA) is a formal request submitted...
Imagine you’ve developed a new medicine that uses living things, like cells or proteins, to fight...
The development of safe and effective new drugs is a cornerstone of the pharmaceutical industry. A critical...
“ Where do you spend the most time preparing PDFs for use in submissions? ”
This was the starting point...
PMA (Premarket Approval) Submissions: Guidance, Process & Requirements
Premarket Approval (PMA) submissions...
The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices....
“How do new medications make it to the pharmacy shelves or to the patients? What steps does it need to...
Have you ever wondered how affordable generic medications reach the market? The answer lies in a process...
Preparing compliant content while there’s a deadline hanging above your head is not easy. Particularly...
If you ever attended one of our webinars, you will have heard us say this a lot.
But, what do we actually...
Regulatory submissions are a very critical milestone in the life sciences industry. They are literally...
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it....
Paris, France – February 6, 2024
Ennov, provider of the only cloud-based unified compliance platform...
1. Save hundreds of hours every month when preparing PDFs for submission-readiness
If regulatory operations...
Introduction
Welcome to a journey through the complexities of PDF compliance within the life sciences....
In our latest edition of the thought leadership series, we were honored to have Dr. Benita von Glahn (Head...
1. Rendering is more than creating a PDF. No matter which document management system you use.
Traditionally,...
DocShifter offers a powerful solution for automating the rendering of Veeva binders, streamlining the...
Introduction:
“Converting to PDF is easy, and everyone does that. The problem is us spending hours and...
Continuing the LinkedIn Live thought leadership series with Aki Yamaguchi from LORENZ Life Sciences Group.
During...
1. Do not wait until the last minute to resolve content-related issues
A typical drug development...
PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple...
Here are 5 ways to automate submission content preparation in Veeva with DocShifter
1. Achieve document...
For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert...
Audio & Video Resources 3
Automated Doc Gen Resources 3
Automated Report Level Publishing Resource 2
Blog
Incoming Email Resources 3
PDF/A & TIFF Resource 3
Submission Ready Pdf Resource 2
Use Cases Resources
Validate and fix PDF Resources 3
Validate and fix Word Resources 3
Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community....
Who is (unfortunately) old enough to remember this?
Date: March 2007.
A submission. 500 binders for Module...
There’s a lot of talk about structured information and how it will solve all our problems with regulatory...
If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading...
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did...
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical...
Life Sciences organisations are required to create huge quantities of documentation to support the marketing...
Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine...
What is enterprise document conversion, and how does a document conversion software impact your business?
Enterprise...
How can you speed up the process of getting your medicinal products approved by health authorities? At...
Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF?
Creating...
The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide....
Understanding Refusal to File (RTF) in the FDA Approval Process
The Food and Drug Administration (FDA)...
China is the most populous country on the planet accounting for more than 18% of the world’s population....
This article answers the most frequently asked questions on the electronic common technical document...
A big thank you to Kathie Clark for joining us in our LinkedIn Live session!
With her extensive experience...
PDFs are more than just static documents — they hold a wealth of data that can be crucial for making...
In our latest edition of the thought leadership series, we were honored to have Dr. Benita von Glahn (Head...
All clinical trial or marketing applications submitted to the FDA must include a form that summarizes...
Continuing the LinkedIn Live thought leadership series with Aki Yamaguchi from LORENZ Life Sciences Group.
During...
With so many mature and emerging digital technologies, and no end of interesting use cases in Regulatory,...
For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert...
Audio & Video Resources 3
Automated Doc Gen Resources 3
Automated Report Level Publishing Resource 2
Blog
Incoming Email Resources 3
PDF/A & TIFF Resource 3
Submission Ready Pdf Resource 2
Use Cases Resources
Validate and fix PDF Resources 3
Validate and fix Word Resources 3
Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community....
Global dossier management is a hot topic for many small and large organizations in life sciences.
Global...
Who is (unfortunately) old enough to remember this?
Date: March 2007.
A submission. 500 binders for Module...
There’s a lot of talk about structured information and how it will solve all our problems with regulatory...
If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading...
Why does AI in Regulatory Content Preparation Matter?
As artificial intelligence technology continues...
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it....
1. Save hundreds of hours every month when preparing PDFs for submission-readiness
If regulatory operations...
1. Rendering is more than creating a PDF. No matter which document management system you use.
Traditionally,...
DocShifter offers a powerful solution for automating the rendering of Veeva binders, streamlining the...
1. For the viewer, a report is just a series of PDF files. But for the author(s), a report means a lot...
1. Do not wait until the last minute to resolve content-related issues
A typical drug development...
PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple...
Here are 5 ways to automate submission content preparation in Veeva with DocShifter
1. Achieve document...
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it....
A Complete Guide to Optical Character Recognition (OCR)
In today’s fast-paced world, businesses need...
In today’s digital age, organizations are generating and handling an unprecedented amount of digital...
Mass digital document transformation is one of those things that your business might only need once or...
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did...
Many of us in business and IT set up and maintain digital archives. Banks, insurance, and healthcare...
Audio & Video Resources 1
Blog
Incoming Email Resources 2
PDF/A & TIFF Resource 2
Use Cases Resources
Whitepaper
What is enterprise file conversion? What does it mean?
Enterprises or businesses deal with a lot of documents,...
What is enterprise document conversion, and how does a document conversion software impact your business?
Enterprise...
Most companies are not demanding when it comes to the file formats they use. They just use the most common...
Infinite scalability in document conversion through container technology
Container technology* has been...
Life Sciences organizations deal with external parties and health authorities on a regular basis. Given...
In an earlier post we explained the importance of digital preservation and why every company should have...
File Format Preservation: What is it?
File format preservation refers to the act of maintaining...
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did...
Many of us in business and IT set up and maintain digital archives. Banks, insurance, and healthcare...
What is enterprise document conversion, and how does a document conversion software impact your business?
Enterprise...
Enterprises work with a lot of digital formats: Microsoft Word, Excel, PowerPoint, JPEG, TIFF, PDF, PDF/A,...
Infinite scalability in document conversion through container technology
Container technology* has been...
The volume of digital information is increasing at warp-time speed. Whether created as a result of the...
When we started our international DocShifter journey 6 years ago, our ambition was to improve the way...
Paris, France – February 6, 2024
Ennov, provider of the only cloud-based unified compliance platform...
We are thrilled to announce that DocShifter is now available on the Microsoft Azure Marketplace! For...
Win-win for partners, customers and end-users
“We are very pleased to strengthen our global...
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical...
DocShifter 6.3 was born as a result of our development team’s hard work. This release is very special...
PeopleScout Technology, a world leader in recruitment process outsourcing (RPO) has recently chosen DocShifter...
We are happy to announce our DocShifter software will be the default enterprise document conversion solution...
We are proud to announce our new partnership with DACHS to meet the growing needs for document conversion...
DocShifter proudly announces its exciting new partnership with Generis Knowledge Management Inc. to provide...
In recent years, the Life Sciences industry has been moving regulatory activities from paper based processes...