Freyr Digital’s Post

🔍 Discover Precision with our Solutions Navigator! Because finding the perfect eCTD plan shouldn’t be complicated. ✅ Answer a few simple questions ✅ Get a plan tailored to your goals ✅ Streamline your regulatory journey 👉 Try it now! https://lnkd.in/gFqSAwAM #eCTD #Lifesciences #findyoursmartectdpartner #FreyrDigital #FreyrSolutions

Did you know? In previous eCTD versions, document replacements were limited to swapping out individual files one-for-one. eCTD v4.0 context groups enable replacing a set of documents as a consolidated unit. Read our Reg Ops Radar post to learn more: https://hubs.ly/Q02CH1qM0 #RegOpsRadar #FDA #eCTD

Challenges and Solutions in Inspecting Drug-Coated Stents Navigating the Complexities: Inspecting drug-coated stents presents unique challenges—microscopic dimensions, non-uniform drug coatings, and stringent regulatory requirements all demand extraordinary precision. #MedicalTechnology #StentInspection Precision Matters: A tiny flaw in a drug-coated stent can lead to serious complications. Advanced imaging and inspection technologies are crucial for identifying micro-level defects that traditional methods miss. #PatientSafety #QualityControl Overcoming Inspection Challenges: From advanced imaging systems like OCT to automated visual inspection, technology is paving the way for more efficient and reliable inspections of drug-coated stents. #Innovation #HealthcareTech https://lnkd.in/d4rFARC6

As we conclude our 12-week blog series exploring the transition from eCTD 3.2.2 to eCTD 4.0, it's essential to reflect on the key considerations and potential benefits for sponsors. Read our final RegOps Radar post to learn more: https://hubs.ly/Q02JMrcG0 #RegOpsRadar #FDA #eCTDv4

🌟 𝗔𝗱𝗮𝗽𝘁𝗶𝗻𝗴 𝘁𝗼 𝘁𝗵𝗲 𝗙𝘂𝘁𝘂𝗿𝗲 𝗼𝗳 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻𝘀 🌟 We see eCTD 4.0 not only as a regulatory requirement, but also as an opportunity to enhance your regulatory operations with a partner who understands your needs. With LORENZ, transitioning to eCTD 4.0 is seamless as our format-independent solution allows for easy implementation of any future format. Let’s shape the future of submissions together. 🚀 Click here for more information: https://lnkd.in/eKa2N4AD #Innovation #eCTD4 #RegulatoryExcellence #LifeSciences #justanotherformat

Introducing BD Pyxis™ PharmacyKeeper™ Verification with gravimetric guided workflows. Learn how our new solution supports compounding safety: https://lnkd.in/ePfYDR9h #BDemployee https://bit.ly/3BmQ0fY

Medical Business Advisors, a division of our sister company, BlueStone Services, is here to help you with everything you need when preparing for a CAP lab inspection. Watch this short video where our team discusses common challenges, tips to prepare and more

Medical Business Advisors, a division of our sister company, BlueStone Services, is here to help you with everything you need when preparing for a CAP lab inspection. Watch this short video where our team discusses common challenges, tips to prepare and more

Medical Business Advisors, a division of our sister company, BlueStone Services, is here to help you with everything you need when preparing for a CAP lab inspection. Watch this short video where our team discusses common challenges, tips to prepare and more

Medical Business Advisors, a division of our sister company, BlueStone Services, is here to help you with everything you need when preparing for a CAP lab inspection. Watch this short video where our team discusses common challenges, tips to prepare and more