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? Our tips will help you streamline the whole regulatory submission process. For Life Sciences companies, […]
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 and authors working on the same document, each with their styling, getting this consistency is almost an impossible mission. Do […]
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 comes first, which is why the process of bringing a drug to the market takes many years (from 8 […]
Refusal to File: Reducing FDA Non-compliance Risk

Understanding Refusal to File (RTF) in the FDA Approval Process The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and efficacy of drugs entering the U.S. market. One important tool in this process is the Refusal to File (RTF) mechanism. Bringing a new medicine or a product to the market […]
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 to be converted at some point; for various reasons: standardization, regulatory compliance, digital archiving, customer communication and many more. Not an easy task, as documents live in different systems, versions, […]
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 remotely, as entire team was working from home. Impressive work. DocShifter 6.3 […]
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 decision at PeopleScout with numbers. How did automated document and PDF conversion impact Chris’ daily activities at PeopleScout? DocShifter is the […]
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 to serve a larger range of clients with expanded document conversion functionalities. New CARA cloud offering provides an enterprise […]
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 ranking rose from 9th largest in 2007 to 2nd in 2017. To help expedite the review and approval […]
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 extension of their software tools. The best example is the Microsoft Office package. Although Word is a good program for word processing, text editing and file formatting, a Word-file (.docx) […]