Blog & Knowledge Sharing

PDF requirements for US FDA submissions (Free checklist)

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 properly documented, a typical R&D process generates a lot of documents. And in a lot of different…
Document conversion software for enterprises: which solution should I choose? | Blog post by DocShifter

Document conversion software for enterprises: which solution should I choose?

What is enterprise document conversion and how does that impact your business?  Enterprise document conversion is the process of converting different digital file formats into other formats so that they can be used in various business processes…

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 wide range of functionalities and many more.  In knowledge-driven industries, the need for standardization…
3 tips to save time and reduce risk in regulatory submissions (Submissions to FDA, EMA, PMDA, HC and other health authorities). How do you streamline regulatory submissions to save time and reduce risks?

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 risk of submitting PDFs that are not complying with technical requirements in your regulatory submissions?…

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 changes into PDF is a big challenge. With multiple reviewers…
Is data taking over the role of PDF in regulatory?

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 affordable and easily accessible medicinal products. Patient and patient safety always…
Don't let an RTF become your worst nightmare

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 may vary from one Health Authority (HA) to another, there are some general stages that the medicine must go…
How to speed up PDF conversion by 10x in 2021 - DocShifter Blogpost.

How to speed up PDF conversion by 10X in 2021

Introduction Compliance is never far away in the Life Sciences industry. The different health authorities across the globe have set out very specific guidelines when it comes to providing documentation and data. For the right reasons. Life…
DocShifter 6.3 | New Release that focuses on improved functionalities.

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 up to industry leading rendering capabilities but also because of how it was built. 6.3 was built completely…
success story

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. System administrator Chris Bellgard explains the impact of this…
Generis and DocShifter work together for a conversion solution in the new CARA cloud offering

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 further strengthen the bond between organizations and allows the new CARA…
Successful eCTD Implementation in China: 3 Lessons Learned

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 by the Chinese government in the last decade, the country’s global industry…