Free FDA PDF Specifications Checklist
We’ve created a checklist to help you optimize your PDF documents for eCTD submissions. Enter your email below and we’ll send it directly to you.
3 ways to automate Report Generation with DocShifter
1. For the viewer, a report is just a series of PDF files. But for the author(s), a report means a lot of hard (manual)
The impact of automated PDF checking & fixing at a large pharma company: A customer case study by DocShifter
Introduction: “Converting to PDF is easy, and everyone does that. The problem is us spending hours and hours of time on editing PDFs with Acrobat,
Expansion to India! Exciting times ahead. (Press Release)
Win-win for partners, customers and end-users “We are very pleased to strengthen our global presence through this valuable partnership” said Geert Van Peteghem, CEO
eCTD Global Aspects and Future Directions (LinkedIn Live Session)
Continuing the LinkedIn Live thought leadership series with Aki Yamaguchi from LORENZ Life Sciences Group. During this LinkedIn live session, Mr. Yamaguchi and Paul Ireland
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[Webinar Summary] How to automate PDF rendering with DocShifter
1. Do not wait until the last minute to resolve content-related issues A typical drug development process takes from 5 and 15 years, and
Dynamic Scalability in Document Conversion: What is it? What are the benefits?
In today’s digital age, organizations are generating and handling an unprecedented amount of digital documents in various file formats. From invoices and reports to contracts
Accelerating submission-ready PDF rendering. A case story by PharmaLex.
PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple clients and therefore receives large numbers of documents in a variety of formats and
5 ways to automate your submission content preparation in Veeva with DocShifter
1. Achieve document compliance earlier in your submission process when using DocShifter with Veeva (or any other repository) A typical drug development process takes from
The Economics of Technology Innovation in Regulatory
With so many mature and emerging digital technologies, and no end of interesting use cases in Regulatory, how do we decide which ones are worth
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
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
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
The Evolving State of Global Dossier Management
Global dossier management is a hot topic for many small and large organizations in life sciences. Global dossier management is a challenging concept on its
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.
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
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
What You Should Know About Document Transformation Services
Mass digital document transformation is one of those things that your business might only need once or twice. System migration, archiving or regulatory requirements are
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
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
Pharma time-to-market reduced thanks to more efficient submission document publishing services
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of
How to design or implement an enterprise file conversion platform?
What is enterprise file conversion? What does it mean? Enterprises or businesses deal with a lot of documents, in multiple formats. Word, Excel, PowerPoint, PDF,
How to reduce regulatory content creation issues? 4 tips.
Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been
Free checklist for PDF format specifications for FDA submissions
Pharmaceutical and biotechnology companies spend a lot of effort in the R&D process of a new medicine or a product. As every stage must be
Document conversion software for enterprises: which solution should I choose?
What is enterprise document conversion, and how does a document conversion software impact your business? Enterprise document conversion is the process of converting different digital
6 Rocking Reasons to Rethink Document Rendering
We have been rendering various documents into a unified format such as PDF for many years now. For many reasons: ease of use, accessibility, a
3 tips to save time and reduce risk in regulatory submissions
How can you speed up the process of getting your medicinal products approved by health authorities? At the same time, how can you reduce the
Track changes and comments don’t look consistent when you convert Microsoft Word documents to PDF?
Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF? Creating consistent output when converting MS Word documents containing track
Is data taking over the role of PDF in eCTD submissions?
The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with
Refusal to File (RTF) and how modern rendering can reduce non-compliance risk
Bringing a new medicine or a product to the market is a complex process that typically takes from 8 to 14 years. Although this process
How to speed up PDF conversion by 10X in 2021
Enterprises work with a lot of digital formats: Microsoft Word, Excel, PowerPoint, JPEG, TIFF, PDF, PDF/A, video and audio files. All these digital files need
DocShifter 6.3 is rocking rendering again with new and improved functionality
DocShifter 6.3 was born as a result of our development team’s hard work. This release is very special to us, not only because it adds
PeopleScout significantly improves efficiency and speed in document and PDF conversion with DocShifter
PeopleScout Technology, a world leader in recruitment process outsourcing (RPO) has recently chosen DocShifter to convert all incoming digital formats to high quality PDF files.
DocShifter powers the document conversion solution in Generis new CARA cloud offering
We are happy to announce our DocShifter software will be the default enterprise document conversion solution in Generis’ new CARA cloud offering. The integration will
Successful eCTD Implementation in China: 3 Lessons Learned
China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development
6 Valuable Tips: Why should you convert to PDF?
Most companies are not demanding when it comes to the file formats they use. They just use the most common file formats as the logical
How Docker puts your rendering farm on steroids
Infinite scalability in document conversion through container technology Container technology* has been around for a while now. The benefits are clear: scalability, rapid deployment, cost
5-Step Automation: Reduce Risks in Correspondence Tracking and your incoming e-mail conversion
Life Sciences organizations deal with external parties and health authorities on a regular basis. Given the amount of information, tracking all that communication is very
What are the key disruptors for Life Sciences?
Every industry goes through changes over time and the Life Sciences industry is no exception. But not every change is significant. With so many buzzwords
6 good reasons why leading Life Sciences companies are rethinking their Document Rendering Solution
We have been converting divergent documents into a unified format such as PDF for many years now. In knowledge-driven industries such as Life Sciences in
What’s next after eCTD?
Life sciences companies face enormous challenges to comply to the increasingly complex regulatory environments. More and more companies adopt the fully electronic eCTD submission format.
DACHS Biosciences and DocShifter Partner Up to Help Life Sciences Companies Deal With the Growing Challenges Around Advanced Document Conversion
We are proud to announce our new partnership with DACHS to meet the growing needs for document conversion & enrichment in the Life Sciences industry.
Generis and DocShifter Partner to Provide Compliant Content for Life Sciences
DocShifter proudly announces its exciting new partnership with Generis Knowledge Management Inc. to provide industry-leading rendition handling as part of their CARA toolsuite. The advanced
Why and how to preserve your digital archive?
The volume of digital information is increasing at warp-time speed. Whether created as a result of the digitising of non-digital collections, as a digital publication
Expansion to Japan thanks to eSA partnership
In recent years, the Life Sciences industry has been moving regulatory activities from paper based processes to fully digital. During this shift, they are facing enormous
Strator recommends DocShifter because of attractive ROI
Our partner Strator helps companies with everything to do with documents, with a wide range of hand-picked technologies, deep business understanding and long experience. They
Frequently asked questions on the eCTD format (Part 2)
The electronic submission requirements (CDER/CBER) will apply to the following types of submissions:
Frequently asked questions on the eCTD submission format (Part 1)
This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences
A closer look into the eCTD triangle and its modules
CTD is a well known term in the Life Sciences industry, and stands for Common Technical Document. This internationally agreed format contains a set of
