New FDA Forms for INDs, NDAs, and BLAs: What to Know Before Submitting
All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. Periodically, the FDA updates these forms to enhance their usability and incorporate relevant content to help sponsors and reviewers. Both forms represent […]
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) 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 these […]
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, 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 […]
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 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. […]
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 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 […]
[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 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 or after […]
Dynamic Scalability in Document Conversion: What is it?
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 and customer records, the need to convert documents from one format to another is an everyday requirement. However, managing the conversion process efficiently is challenging, especially when faced with fluctuating […]
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 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 […]
5 ways to automate your submission content preparation in Veeva with DocShifter
Here are 5 ways to automate 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 5 and 15 years, and documentation is created every step of the way. Marketing Authorisation submissions are compiled […]
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 it? And most importantly, who pays vs who benefits? This was the topic during our third LinkedIn live session with John Cogan. For those who missed the live event, the […]