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
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,
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
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
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
PDFs are more than just static documents — they hold a wealth of data that can be crucial for making timely, informed decisions. We wanted
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
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
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
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
“ Where do you spend the most time preparing PDFs for use in submissions? ” This was the starting point for this webinar. We asked
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,
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
“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
Have you ever wondered how affordable generic medications reach the market? The answer lies in a process known as an ANDA submission, or Abbreviated New
Preparing compliant content while there’s a deadline hanging above your head is not easy. Particularly for clinical research organization (CRO) and regulatory service providers. The
If you ever attended one of our webinars, you will have heard us say this a lot. But, what do we actually mean by ‘achieve
Regulatory submissions are a very critical milestone in the life sciences industry. They are literally the translation of (mostly) 10 years’ worth of R&D work
Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it. The technology that makes it possible to significantly speed up
Paris, France – February 6, 2024 Ennov, provider of the only cloud-based unified compliance platform for life sciences – a highly configurable software architecture that
1. Save hundreds of hours every month when preparing PDFs for submission-readiness If regulatory operations teams could have a wish, one would be to have
Introduction Welcome to a journey through the complexities of PDF compliance within the life sciences. This article aims to enlighten you on various critical aspects:
In our latest edition of the thought leadership series, we were honored to have Dr. Benita von Glahn (Head Global Regulatory Affairs and member of the R&D
1. Rendering is more than creating a PDF. No matter which document management system you use. Traditionally, rendering has often been viewed as a straightforward
DocShifter offers a powerful solution for automating the rendering of Veeva binders, streamlining the process and ensuring submission-ready PDF reports. Binders are being used by almost
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,
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
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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
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
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
For this month’s edition, we knocked on Daniel Capion‘s door. Daniel is a documentation expert with +20 years of experience from biotech, mid-sized and big-pharma industry
Get the latest updates & trends in Life Sciences in our free Regulatory Professionals Community. Tips & tricks for regulatory submissions, eCTD 4.0 and many
Who is (unfortunately) old enough to remember this? Date: March 2007. A submission. 500 binders for Module 5, 60 binders for Module 4, 30 binders
There’s a lot of talk about structured information and how it will solve all our problems with regulatory submissions. If you look at initiatives such
If you work in Regulatory Operations, you are probably knee-deep in transformation. Whether you are upgrading your entire RIM system (or parts of it), or
Document rendering is viewed by many as simple document-to-PDF conversion. Nothing more. However, did you know that document rendering can actually do a lot more
PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of
Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been
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
What is enterprise document conversion, and how does a document conversion software impact your business? Enterprise document conversion is the process of converting different digital
How can you speed up the process of getting your medicinal products approved by health authorities? At the same time, how can you reduce the
Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF? Creating consistent output when converting MS Word documents containing track
The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with
Understanding Refusal to File (RTF) in the FDA Approval Process The Food and Drug Administration (FDA) plays a critical role in ensuring the safety and
China is the most populous country on the planet accounting for more than 18% of the world’s population. Following the focus placed on biopharmaceutical development
This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences
15 years of experience in automating, simplifying and speeding up document conversion. For all regulated industries. Rated 5 stars on Gartner’s Capterra platform.
