Entourage

🚀 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞 𝐘𝐨𝐮𝐫 𝐃𝐞𝐬𝐢𝐠𝐧 𝐓𝐫𝐚𝐧𝐬𝐟𝐞𝐫 𝐟𝐨𝐫 𝐂𝐨𝐦𝐛𝐢𝐧𝐚𝐭𝐢𝐨𝐧 𝐏𝐫𝐨𝐝𝐮𝐜𝐭𝐬 🚀   Navigating the design transfer process for combination products? From regulatory challenges under 𝐄𝐔 𝐌𝐃𝐑 to compliance with 𝐅𝐃𝐀 21 𝐂𝐅𝐑 𝐏𝐚𝐫𝐭 4, we understand the complexities involved.   At Entourage, we offer a structured approach to ensure a smooth and efficient design transfer, focusing on 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞, 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 𝐨𝐩𝐭𝐢𝐦𝐢𝐳𝐚𝐭𝐢𝐨𝐧, and 𝐫𝐢𝐬𝐤 𝐦𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 to help you avoid delays and bring your product to market faster.   💡 Interested in learning how we can support your design transfer?   📲 Contact Dominique HOFF to discuss how Entourage can assist with your journey!   #designtransfer #CombinationProducts #RegulatoryCompliance

🌍 𝐆𝐥𝐨𝐛𝐚𝐥 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧𝐬 – 𝐀𝐜𝐜𝐞𝐥𝐞𝐫𝐚𝐭𝐞𝐝 🚀 Facing challenges with specific regulatory landscapes for software approvals? We understand the hurdles. Recently, we supported the successful approval of 𝐄𝐔 𝐜𝐥𝐚𝐬𝐬 𝐈𝐈𝐛 𝐬𝐭𝐚𝐧𝐝𝐚𝐥𝐨𝐧𝐞 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞 in 50 countries, overcoming regulatory complexities and lengthy review processes.   Interested in how we can accelerate your software’s global market entry and ensure compliance across multiple regions? 💡   🔗 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐜𝐚𝐬𝐞 𝐬𝐭𝐮𝐝𝐲 𝐡𝐞𝐫𝐞 https://lnkd.in/gA2SKgk8 and see how our tailored solutions make a difference.   #RegulatoryAffairs #GlobalMarketEntry #SoftwareApproval #MedicalDevices #classIIb

🎤 𝐄𝐧𝐭𝐨𝐮𝐫𝐚𝐠𝐞 𝐚𝐭 𝐑𝐀𝐏𝐒 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐢𝐧 𝐁𝐚𝐫𝐜𝐞𝐥𝐨𝐧𝐚! 🇪🇸 We’re excited to announce that Dr. Jennifer Neff, Dr. Irina Idler, M.Sc., and Sven Hoffmann from Entourage will be speaking at the RAPS European 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥, 𝐑𝐢𝐬𝐤, 𝐚𝐧𝐝 𝐏𝐨𝐬𝐭𝐦𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 on October 23 and 24, 2024 in Barcelona! Dr. Jennifer Neff will be hosting: 💡 𝘗𝘳𝘦𝘤𝘰𝘯𝘧𝘦𝘳𝘦𝘯𝘤𝘦 𝘞𝘰𝘳𝘬𝘴𝘩𝘰𝘱: 𝘌𝘧𝘧𝘦𝘤𝘵𝘪𝘷𝘦 𝘙𝘪𝘴𝘬 𝘔𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵 𝘢𝘵 𝘵𝘩𝘦 𝘊𝘰𝘳𝘦 𝘰𝘧 𝘔𝘋𝘙 𝘢𝘯𝘥 𝘐𝘝𝘋𝘙 on October 22 and moderating the 💡 𝘖𝘱𝘦𝘯𝘪𝘯𝘨 𝘗𝘭𝘦𝘯𝘢𝘳𝘺 𝘚𝘦𝘴𝘴𝘪𝘰𝘯: 𝘌𝘷𝘰𝘭𝘷𝘪𝘯𝘨 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘍𝘳𝘢𝘮𝘦𝘸𝘰𝘳𝘬𝘴: 𝘈𝘤𝘤𝘦𝘴𝘴 𝘵𝘰 𝘐𝘯𝘯𝘰𝘷𝘢𝘵𝘪𝘰𝘯 𝘢𝘯𝘥 𝘗𝘢𝘵𝘪𝘦𝘯𝘵 𝘚𝘢𝘧𝘦𝘵𝘺 Dr. Irina Idler, M.Sc. will be discussing: 💡 𝘛𝘩𝘦 𝘐𝘯𝘵𝘦𝘳𝘧𝘢𝘤𝘦 𝘰𝘧 𝘵𝘩𝘦 𝘌𝘜 𝘈𝘐 𝘈𝘤𝘵 𝘢𝘯𝘥 𝘵𝘩𝘦 𝘔𝘋𝘙/𝘐𝘝𝘋𝘙 Sven Hoffmann will be covering: 💡 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘌𝘷𝘪𝘥𝘦𝘯𝘤𝘦 𝘐𝘝𝘋𝘙 - 𝘍𝘭𝘦𝘹𝘪𝘣𝘭𝘦 𝘊𝘰𝘯𝘤𝘦𝘱𝘵𝘴 𝘵𝘰 𝘚𝘢𝘵𝘪𝘴𝘧𝘺 𝘕𝘉 𝘌𝘹𝘱𝘦𝘤𝘵𝘢𝘵𝘪𝘰𝘯𝘴 💡 𝘗𝘰𝘴𝘵-𝘔𝘢𝘳𝘬𝘦𝘵 𝘚𝘶𝘳𝘷𝘦𝘪𝘭𝘭𝘢𝘯𝘤𝘦 𝘶𝘯𝘥𝘦𝘳 𝘔𝘋𝘙 𝘢𝘯𝘥 𝘐𝘝𝘋𝘙: 𝘗𝘳𝘢𝘤𝘵𝘪𝘤𝘢𝘭 𝘐𝘯𝘴𝘪𝘨𝘩𝘵𝘴 𝘞𝘩𝘦𝘳𝘦 𝘌𝘧𝘧𝘪𝘤𝘪𝘦𝘯𝘤𝘺 𝘔𝘦𝘦𝘵𝘴 This is a fantastic opportunity to gain insights into critical regulatory topics directly from our experts. We’re looking forward to engaging with industry leaders and sharing knowledge on the evolving regulatory landscape. 🗓️ 𝐒𝐚𝐯𝐞 𝐭𝐡𝐞 𝐃𝐚𝐭𝐞: 23rd and 24th October 2024 📍 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧: Barcelona, Spain Let’s connect at the event! Drop us a message if you'd like to meet or learn more. #RAPS2024 #RegulatoryAffairs #oneEntourage

🌟 𝐓𝐡𝐚𝐧𝐤 𝐘𝐨𝐮 𝐟𝐨𝐫 𝐚𝐧 𝐈𝐧𝐜𝐫𝐞𝐝𝐢𝐛𝐥𝐞 𝐂𝐏𝐡𝐈 𝐌𝐢𝐥𝐚𝐧 🌟 What a fantastic few days it’s been at CPHI 2024 in Milan! We were thrilled to connect with so many partners and industry leaders. A special highlight was seeing our Italian team led by Claudio Puglisi, our Managing Director for Italy, and welcoming such a large turnout at our evening event. Your energy made the event truly special! 🎉 Our Pharma Germany team was also well-represented, with our Managing Partner Moritz Haucke and Principal Consultant Patrizia Piscopiello joining the conversations on the latest pharma trends and innovations. 💡 It was a pleasure to catch up with so many familiar faces and meet new connections, all contributing to the future of the pharmaceutical industry. We’re already looking forward to next year’s CPhI and continuing our work together. Until then, thank you for your continued trust and collaboration. 🙌 Let’s keep the momentum going! 🚀 #CPHI #OneEntourage #Pharma

🔍 𝐅𝐚𝐜𝐢𝐧𝐠 𝐏𝐫𝐨𝐜𝐮𝐫𝐞𝐦𝐞𝐧𝐭 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐢𝐧 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬? 🔍 In the dynamic world of life sciences, procurement can often present complex challenges. Are you experiencing any of the following issues? ⚡ 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐆𝐚𝐩𝐬: Is reactive planning slowing down your progress? 🚧 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐒𝐭𝐚𝐠𝐧𝐚𝐭𝐢𝐨𝐧: Are you struggling to drive innovation and value creation? 📊 𝐃𝐚𝐭𝐚 𝐃𝐢𝐬𝐜𝐫𝐞𝐩𝐚𝐧𝐜𝐢𝐞𝐬: Does a lack of data transparency block your optimization efforts? 🚨 𝐑𝐢𝐬𝐤 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐃𝐞𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐢𝐞𝐬: Are you facing gaps in risk management and outsourcing strategies? ⛔ 𝐑𝐞𝐬𝐨𝐮𝐫𝐜𝐞 𝐋𝐢𝐦𝐢𝐭𝐚𝐭𝐢𝐨𝐧𝐬: Are limited resources hindering your efficiency and growth? Entourage, led by Tim Schnieder and his team, is here to help to navigate through the procurement with tailored solutions for the life sciences sector, we can overcome these challenges together. 𝐋𝐞𝐭’𝐬 𝐭𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦 𝐲𝐨𝐮𝐫 𝐩𝐫𝐨𝐜𝐮𝐫𝐞𝐦𝐞𝐧𝐭 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐟𝐨𝐫 𝐬𝐮𝐜𝐜𝐞𝐬𝐬!  🚀 Reach out directly or comment below to start the conversation. ✉️   #ProcurementExcellence #SupplyChainManagement #DigitalTransformation

🚀 We’re excited to join forces with TÜV SÜD for an upcoming webinar on "𝐔𝐧𝐝𝐞𝐫𝐬𝐭𝐚𝐧𝐝𝐢𝐧𝐠 𝐈𝐕𝐃𝐑 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐄𝐯𝐢𝐝𝐞𝐧𝐜𝐞 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬". Entourage’s very own Dr. Sebastian Grömminger will be joining Dr. Heike Möhlig-Zuttermeister from TÜV SÜD for an insightful discussion on navigating the IVDR life cycle concept and ensuring the continuous safety and performance of state-of-the-art IVDs. 🗓️ Date: 09 October 2024 ⏰ Session 1: 9am-10am CET / 3pm-4pm SGT / 3am-4am EST ⏰ Session 2: 3pm-4pm CET / 9pm-10pm SGT / 9-10am EST Don’t miss this opportunity to gain exclusive insights from leading experts in the field. Secure your spot now and stay ahead of the regulatory curve! 👉 Register here: https://lnkd.in/dM9C-u2M #IVDR #IVD #MedicalDevices #IVDRegulations #medtech

📢 𝐉𝐨𝐢𝐧 𝐔𝐬 𝐟𝐨𝐫 𝐚𝐧 𝐈𝐕𝐃𝐑 𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐘𝐨𝐮 𝐃𝐨𝐧’𝐭 𝐖𝐚𝐧𝐭 𝐭𝐨 𝐌𝐢𝐬𝐬! We’re excited to partner with TÜV SÜD for the upcoming webinar, "𝘜𝘯𝘥𝘦𝘳𝘴𝘵𝘢𝘯𝘥𝘪𝘯𝘨 𝘐𝘝𝘋𝘙 𝘊𝘭𝘪𝘯𝘪𝘤𝘢𝘭 𝘌𝘷𝘪𝘥𝘦𝘯𝘤𝘦 𝘙𝘦𝘲𝘶𝘪𝘳𝘦𝘮𝘦𝘯𝘵𝘴." Our very own Dr. Sebastian Grömminger, Principal Consultant IVD at Entourage, will be sharing his expertise alongside Dr. Heike Moehlig-Zuttermeister-Zuttermeister from TÜV SÜD. 💡 This webinar will dive deep into optimal strategies for managing IVDR Clinical Evidence requirements, with topics including: ✔️ A continuous approach to the IVDR Clinical Evidence concept ✔️ Lessons learned from nearly 5 years of IVDR NB experience ✔️ Understanding the clinical performance concept ✔️ Clinical Evidence strategies – leveraging the right data 🗓️ 𝐒𝐚𝐯𝐞 𝐭𝐡𝐞 𝐃𝐚𝐭𝐞: 09 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 2024 🔗 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐧𝐨𝐰 𝐚𝐧𝐝 𝐬𝐞𝐜𝐮𝐫𝐞 𝐲𝐨𝐮𝐫 𝐬𝐩𝐨𝐭: https://lnkd.in/dM9C-u2M Don’t miss this opportunity to gain invaluable insights from industry leaders. We look forward to seeing you there! #TUVSUD #IVDR #MedicalDevices #Entourage #Webinar #IVD #RegulatoryAffairs

🔍 𝐂𝐚𝐭𝐜𝐡 𝐄𝐧𝐭𝐨𝐮𝐫𝐚𝐠𝐞 𝐚𝐭 𝐑𝐀𝐏𝐒 𝐂𝐨𝐧𝐯𝐞𝐫𝐠𝐞𝐧𝐜𝐞 💼 We’re thrilled to announce that our Head of Medical Devices & Principal Consultant, Dr. Jennifer Neff, will be representing Entourage at Regulatory Affairs Professionals Society (RAPS) Convergence 2024 in Long Beach, California! 🎉 Jennifer is excited to engage with industry experts and exchange knowledge at one of the most important regulatory events of the year. If you’re attending, make sure to stop by TT-6 and connect with Jennifer to explore the latest trends and innovations in the medical device industry. 🚀 We’d love to see you there—let’s collaborate and share expertise! #RAPSConvergence2024 #oneentourage #MedicalDevices #RegulatoryAffairs #KnowledgeSharing #Collaboration

#Hiring – Wir suchen eine:n neue:n Senior Specialist Artwork Coordination (80-100%) in Winterthur, Zurich. Bewerben Sie sich noch heute oder teilen Sie diese Stellenanzeige mit Ihrem Netzwerk.

#combined #products #designtransfer #devices #drugs The existing #regulations are already effective quite some time and the issues with regulations from the EU (#EUMDR) are mostly that there is still unclarity how the EU will enforce the regulations in the industry.   It is better defined in the #FDA guidance #21CFRpart4, but companies are still struggling since the path between Medical Devices and Drug Products regulations is still in a grey zone. ✅ Are you facing issues while transferring your #combined #products from #development to #operations? ✅ You do not have internally the needed ressources combining medical devices and operations expertises? Entourage could help you to manage your design transfers activities to go to a state-of-the-art and operational stage for your drugs. We work daily with experts in this field and they can help you to manage the complexitiy of your transfer projects.   Do not hesitate to contact me or Kathrin Vernice. We have the solution! #lifesciences #pharma #medicaldevices #combinedproducts #designtransfer #techtransfers #advising #consulting #operations