The Hidden Value of PDFs: Unlocking Insights for Faster Decision Making
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 […]
Investigational New Drug (IND) Application Process: An A-Z Guide
The development of safe and effective new drugs is a cornerstone of the pharmaceutical industry. A critical step in this process is obtaining approval from the Food and Drug Administration (FDA) to initiate clinical trials in humans. This authorization is secured through the submission of an Investigational New Drug (IND) application. What is an IND […]
Practical PDF preparation automation examples and their benefits for you
“ Where do you spend the most time preparing PDFs for use in submissions? ” This was the starting point for this webinar. We asked this question to more than 1000 people that are involved in PDF preparation for regulatory submissions; of organizations of all sizes. We wanted to share the results of this survey; […]
PMA Submissions: Guidance, Process & Requirements
PMA (Premarket Approval) Submissions: Guidance, Process & Requirements Premarket Approval (PMA) submissions are the cornerstone of obtaining FDA clearance for high-risk Class III medical devices, demonstrating their safety and efficacy through a rigorous regulatory review process. PMA submissions hold immense importance for medical device manufacturers seeking market authorization for their innovative creations. They ensure patients […]
A Complete Guide to 510(k) Submissions for Medical Devices (2024)
The U.S. Food and Drug Administration (FDA) regulates the safety and effectiveness of medical devices. To bring a new medical device to market in the United States, manufacturers must demonstrate its compliance with these regulations. This is where the 510(k) premarket notification comes in. A 510(k) submission is an application submitted to the FDA before […]
What are New Drug Applications? A Complete Guide to NDAs
“How do new medications make it to the pharmacy shelves or to the patients? What steps does it need to go through?” The answer lies in a document called a New Drug Application (NDA). An NDA is a comprehensive package submitted to regulatory authorities by drug developers. It essentially tells the full story of a […]