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 […]
Achieving Regulatory Excellence: Must-Have Attributes
PDFs are more than just static documents — they hold a wealth of data that can be crucial for making timely, informed decisions. We wanted to build a live session around PDFs. Not so much around how to create them efficiently; like we typically explain in our webinars, but really about how to unlock all […]
DocShifter Named Top Innovator in Regulatory Software Providers List!
When we started our international DocShifter journey 6 years ago, our ambition was to improve the way people dealt with documents in regulated industries: life sciences, finance, public sector. We wanted to take away the frustration of manually dealing with documents; and make their lives easier with automation. 6 years later, here we are. Working […]
Everything About Marketing Authorisation Application (MAA) Submissions
An MAA submission is a comprehensive dossier submitted by a pharmaceutical company to regulatory authorities seeking permission to market a new medicinal product. In this guide, we will explore everything you need to know about MAA submissions. Stick until the very end, and you will find a link to our Regulatory Professionals Community on LinkedIn […]
CTA Submissions: Guidance, Process & Requirements
What is a Clinical Trial Application (CTA)? A Clinical Trial Application (CTA) is a formal request submitted to regulatory authorities to conduct a clinical trial involving human subjects. It’s a comprehensive document outlining the study’s objectives, methodology, risks, and benefits. Purpose and Importance The primary purpose of a CTA is to ensure the safety and […]
Biologics License Application (BLA) Guide
Imagine you’ve developed a new medicine that uses living things, like cells or proteins, to fight disease. This medicine is called a biologic product. BLA applications are essentially permission slips you need from a health authority, like the FDA in the US, to sell this new biologic product. The application tells the health authority all […]