AI in Regulatory Submissions: How FDA, EMA, and Global Authorities Are Leading the Change
Remember the old days of regulatory submissions? You’d spend months compiling documents by hand, double-checking every cross-reference, running endless quality checks. It was exhausting. AI and machine learning are changing everything—and here’s the surprising part: regulators are the ones pushing this forward. The FDA, EMA, and other health authorities aren’t just accepting AI; they’re actively […]
Introducing DocShifter 9.1! Powered by YOUR feedback.
DocShifter 9.1 is here!. It’s an update built 100% on your valued input! This new version is set to take your document conversion and content management processes to the next level. DocShifter 9.1 brings a host of powerful new features and essential improvements designed to enhance performance, usability, and integration across your enterprise. We’ll share […]
Planning to implement eCTD v4.0? Here is what we learned during our Pilot.
A big thank you to Leigh Sandwell, Publishing Regional Director (EU/ROW) at Pfizer, for joining us in our LinkedIn Live session. With his extensive experience leading global regulatory publishing initiatives, Leigh shared valuable insights from Pfizer’s pilot of eCTD v4.0, and what this next-generation standard means for the future of regulatory submissions. What did we […]
Top 8 Regulatory Podcasts In The Life Sciences Industry
The success of podcasts has been on the rise for the past few years. Our kids have been trying to convince me for a long time 🙂. They are easily accessible and digestible, and can easily be found on many platforms. How about podcasts for regulatory? Well, there are certainly a couple of podcasts that […]
ICH M11: Towards a Digital Future (LinkedIn Live Session Recording)
A big thank you to Kathie Clark for joining us in our LinkedIn Live session! With her extensive experience in content management for the Life Sciences industry (eTMF, CTMS, Regulatory EDMS, submission publishing, RIM, QMS), Kathie shared her insights about the impact of ICH M11, and the transition to data-driven content and processes. What did […]
AI Applied In Content Preparation: Translation & Redaction
Why does AI in Regulatory Content Preparation Matter? As artificial intelligence technology continues to evolve, its use cases in regulatory content preparation are becoming more and more common. Global regulatory submissions demand high volumes of precise documentation, often in multiple languages and formats. The traditional methods of translation and redaction in regulatory content preparation […]
510k Submission Checklist
510k submission checklist Get access to all 510(k) submission formatting specifications via our downloadable checklist. Enter your email below, and download the PDF version right away. Additional resources on 510k and regulatory submissions 510(k) Submissions Read this guide for a comprehensive understanding of the 510(k) process. See our webinars that focus on accelarating content preparation […]
How To Automatically Check MS Word Documents for Compliance with DocShifter
Manual document preparation for compliance can be both time-consuming and error-prone. Regulatory teams often struggle with ensuring that all documents meet the necessary formatting, style, and compliance requirements, especially when dealing with tight deadlines, and lots and lots of documents These checks involve a series of repetitive tasks, such as reviewing documents for proper formatting, […]
FDA eCTD Validation Criteria: A Comprehensive Guide
The electronic Common Technical Document (eCTD) has revolutionized the drug development and approval process. By standardizing the format for regulatory submissions, the eCTD has streamlined interactions between pharmaceutical companies and regulatory authorities like the FDA. However, ensuring compliance with FDA eCTD validation criteria remains a complex challenge for many organizations. The Importance of eCTD Submissions […]
Practical PDF preparation examples to make your life easier
The Role of PDFs in Regulatory Submissions: Navigating Challenges and Ensuring Compliance in the Life Sciences Industry PDFs play a crucial role in the life sciences industry, especially when it comes to regulatory submissions, documentation, and communication. Regulatory bodies like the FDA and EMA rely on PDFs as the standard format for submissions due to […]