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How TVT Helps the Top 5 Functions of Regulatory Professionals 🚀 In the fast-paced world of regulatory affairs, professionals are tasked with ensuring that documents meet stringent regulatory standards. Accuracy and efficiency are paramount, and errors can lead to costly delays or compliance issues. TVT document comparison software is designed specifically to support regulatory professionals by making proofreading faster, reducing stress, and increasing output. Explore how TVT can transform your regulatory processes and help you achieve excellence in your regulatory affairs role. https://lnkd.in/eWpPHCmp

New blog alert! 📢 ✍ Understanding the Four Types of Analytical Method Validation Analytical method validation serves as a critical process to guarantee that the methods used for testing various substances are fit for purpose and yield trustworthy results. In this blog, we will delineate four key types of method validation crucial for maintaining quality standards and achieving regulatory compliance. Let’s delve into each of these types to gain a comprehensive understanding of their significance and look to the future of Analytical Method Validation, together. Read the full blog 👉 https://bit.ly/3Ii5ZMc #MethodValidation #MethodDevelopment #Blog #BlogPost #Content #Analytical

It's the one day every 4 years where you get to correct a mistake 🤣 Today's #readfirstlegal recommendation is a call out to anyone who isn't a subscriber to Seth Godin's blog to go rectify that mistake 💯. It's free 💰. It's great 👍. It's value 💲 . And it's where I go to every morning with my cup of coffee ☕ https://lnkd.in/g5-S9m6s #readfirstlegal #psfbd #psfcoaching

Explore the roles and methodologies associated with regulatory documentation in a professional context ⚡️ In our new course, Regulatory Documentation: An Introduction, you'll gain an overview of the basic principles of regulatory documentation and learn to evaluate different models and strategies for fostering collaboration in regulatory affairs. This course is designed to give an overview of some basic principles of regulatory documentation from the perspective of regulatory affairs professionals who must lead teams. Learn more: https://bit.ly/3IiaPsK

Discover the power of eCTD 4.0 for streamlining your regulatory submissions. Aquila Solutions offers expert support in eCTD publishing, submissions, and compliance. Trust us to simplify your submission process. #ECTD #ECTDSubmissions #ECTDPublishing #ECTDPublishingServices #ECTDPublishingTools #RegulatoryPublishing #RegulatoryAffairs #RegulatoryCompliance

#NotifiedBody (NB) requirements on Reviewers - #IMDRF/GRRP WG/N40 FINAL:2024 (Edition 2) - #Competence, #Training, and #Conduct #Requirements for #Regulatory #Reviewers Have seen this paragraph? "(...) training on good regulatory review practices such as written and oral communication #skills, #technicalwriting, etc. (...)" I have never ever seen such skills on NB reviewers. You? And if, especially with less to no effect on the documents you offten get confronted from them.

It helps to evaluate regulatory risks at every stage of a project, from inception to commercialization. Early assessment at every stage of a product's lifetime prevents problems and streamlines the regulatory submission procedure. A well-thought-out filing method avoids costly errors and maintains alignment. Learn more: https://lnkd.in/enyJuEfc

How to ensure quality and accuracy for medical device translations? Even minor errors can have serious consequences for user safety, regulatory compliance, brand reputation, and legal liability. To know more about quality assurance in medical document translation, read: https://bit.ly/4d98v5H

We've just launched a new FAQ section on our website! The first set of FAQs is related to the eCTD. We've compiled common questions and answers about electronic Common Technical Document (eCTD) submissions to provide you with a helpful resource. Whether you're new to eCTD or looking to refine your knowledge, our FAQ has got you covered. We’ll continue to update the FAQ page, so contact us if you have additional questions. Check it out now: https://lnkd.in/eDmqwGMu #eCTD #Regulatory #regops #electronicsubmissions #regulatorysubmissions #ways

Services Breakdown Part Two: Document Quality Assurance Services Ensuring that your documents look professional and are complete and accurate is and important step before finalizing documents. Here are the services we provide that can help: Formatting Assistance Assistance with formatting on your documents. Quality Assurance of Standardized Documents Quality assurance and review of any site documents (ICFs, SOPs, IIT protocols, source documents, etc.) for grammar, formatting, and comprehension. A report will be provided with necessary and suggested edits. Note: We are not medical professionals and therefore cannot assess the accuracy of any medical information in documents.