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. 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 […]
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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) work and effort. With so many manual tasks involved, the report creation process is typically very time-consuming and prone to errors. Adopting an automated PDF report generation software significantly streamlines
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Are 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 designed specifically for their creation. Merging multiple
Report Generation Automation with DocShifter (with a practical demo) Read More »
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, or other desktop tools. Especially not knowing what was wrong with the PDFs. And that is what DocShifter does for us.: fixing all our PDFs automatically, or at least telling
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 of DocShifter. “The Indian economy is growing at a rapid pace. And India has rapidly become an important global player in the pharmaceutical industry, where most of our customers operate.
Expansion to India! Exciting times ahead. (Press Release) Read More »
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 will discuss the global aspects and the future direction of the electronic common technical document. What can you expect to see in the video? What is/was the main purpose for
eCTD Global Aspects and Future Directions (LinkedIn Live Session) Read More »
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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 documentation is created every step of the way. Marketing Authorisation submissions are compiled at the end of this timeframe. Documents are typically only checked for compliance either just prior to
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The process of preparing content for submissions is very time-consuming and financially burdensome Using multiple desktop tools, and spending hours or even days, manually editing PDFs to meet the FDA, EMA, PMDA, etc. requirements Manually checking and fixing thousands of PDF files for submission readiness Re-working external content to ensure document compliance Validating content too late, and the risk of missing submission deadlines Authors
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 quality. The documents are a mixture of Administrative (Cover Letter, Application form), Summaries, Quality, Non-Clinical and Clinical content. PharmaLex was previously using licensed PDF plug-in tools to prepare content for
Accelerating submission-ready PDF rendering. A case story by PharmaLex. Read More »
Are you using Veeva to store and manage your submission content? The automation of regulatory content does not need to stop there. Combined with the power of DocShifter, we can take automation to the next level. So you can focus on the content. How will this powerful combination help you save time with the following?
How to automate document preparation & report generation in Veeva with DocShifter Read More »
15 years of experience in automating, simplifying and speeding up document conversion. For all regulated industries. Rated 5 stars on Gartner’s Capterra platform.
