Celegence’s Post

🎉 Last week, teams from across Europe and the UK gathered in the Netherlands to commemorate 6 incredible years of growth, innovation, and collaboration at Celegence – and what a celebration it was! In addition to celebrating our Annual Day, we hosted an exciting #Tech Strategy Workshop that energized our teams to think big about the future of #regulatory innovation. Our collective drive to push boundaries is what continues to set Celegence apart as we tackle the most complex challenges in regulatory affairs with our cutting-edge AI-driven technologies – 𝐂𝐀𝐏𝐓𝐈𝐒™ and 𝐃𝐨𝐬𝐬𝐩𝐥𝐨𝐫𝐞𝐫™. This milestone is more than just a reflection of time – it’s about the shared values, teamwork, and passion that have united us. Over these 6 years, we’ve earned the trust of global #pharmaceutical, #medicaldevice, and #diagnostic companies of all sizes, creating lasting impact through our hands-on expertise and strategic insights. We’re incredibly proud of our clients, team members, and partners for making this journey possible. Here's to many more years of success, innovation, and transformative impact! 🙌 #6YearAnniversary #MilestoneMoment #TechInnovation #AnnualDay #LifeSciences #RegulatoryConsulting #CelegenceTechnologies #AI #CAPTIS #Dossplorer #RegulatoryAffairs

🎉 Exciting News! We are thrilled to announce that Celegence has been selected as a finalist for the 𝐓𝐎𝐏𝐑𝐀 𝐀𝐰𝐚𝐫𝐝𝐬 𝐟𝐨𝐫 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 2024 in the 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐂𝐚𝐭𝐞𝐠𝐨𝐫𝐲! Learn more here: https://lnkd.in/gi774yWp 🏆 We are proud to be recognized in 2 out of 4 finalist places, thanks to our cutting-edge solutions: ➡𝐂𝐀𝐏𝐓𝐈𝐒™ - our AI-powered regulatory software revolutionizing compliance: https://lnkd.in/e__vshzE ➡𝐃𝐨𝐬𝐬𝐩𝐥𝐨𝐫𝐞𝐫™ - our Advanced cloud-based dossier management solution, driving efficiency in document review and submissions: https://lnkd.in/equ8_S55 This recognition showcases our commitment to delivering innovative solutions that help our clients stay ahead in the ever-evolving regulatory landscape. TOPRA - The Organisation for Professionals in Regulatory Affairs #TOPRAAwards2024 #RegulatoryExcellence #Innovation #CAPTIS #Dossplorer #RegulatoryTechnology #LifeSciences

Maurice Bancsi, our Senior Regulatory Affairs Scientist, led a sponsored lunch break session at the #TOPRA #Symposium 2024, which took place in #Rotterdam from 30 September to 2 October. His session on the ‘𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐨𝐟 𝐀𝐈 𝐏𝐡𝐚𝐫𝐦𝐚-𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐢𝐧 𝐭𝐡𝐞 𝐄𝐔 𝐚𝐧𝐝 𝐔𝐒’ explored how #ArtificialIntelligence and #MachineLearning are applied throughout the #ProductLifecycle in the #Pharmaceutical industry. Grateful for the opportunity to contribute to such an important discussion—thank you to TOPRA - The Organisation for Professionals in Regulatory Affairs for hosting!

🔍 Ready to master the complexities of benefit-risk calculations under the EU MDR? Join our webinar titled "𝐓𝐡𝐞 𝐀𝐫𝐭 𝐨𝐟 𝐁𝐞𝐧𝐞𝐟𝐢𝐭-𝐑𝐢𝐬𝐤 𝐂𝐚𝐥𝐜𝐮𝐥𝐚𝐭𝐢𝐨𝐧 – 𝐄𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥 𝐓𝐨𝐨𝐥𝐬 𝐟𝐨𝐫 𝐄𝐔 𝐌𝐃𝐑 𝐌𝐚𝐬𝐭𝐞𝐫𝐲" for practical insights on ensuring compliance with EU MDR requirements. 📅 𝐓𝐮𝐞𝐬𝐝𝐚𝐲, 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 29, 2024 | ⏰ 10:00 𝐀𝐌 – 11:00 𝐀𝐌 𝐄𝐓  🎙 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐞𝐫𝐬: Smridula Hariharan & Rohan Sathe 🗣 𝐋𝐢𝐯𝐞 𝐐&𝐀: Get real-time answers to your questions from industry experts. 👉 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐡𝐞𝐫𝐞: https://lnkd.in/gK9imWP3 Learn how to assess and document benefit-risk profiles accurately, prevent non-conformances, and present quantifiable data that meets Notified Body expectations. Don’t miss your chance to gain expert strategies to streamline your compliance process! Learn more about the session in our webinar blog: https://lnkd.in/gkvxUJgu #MDR #EUCompliance #BenefitRisk #Webinar #MedicalDevices #EUMDR #RegulatoryCompliance #HealthcareTech #EURegulations #MedTech

💡𝐊𝐞𝐲 𝐓𝐚𝐤𝐞𝐚𝐰𝐚𝐲𝐬 𝐟𝐫𝐨𝐦 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐁𝐞𝐬𝐭 𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐞𝐬 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐂𝐨𝐦𝐩𝐚𝐧𝐢𝐞𝐬 As #regulatory demands for medical device suppliers continue to rise, the need for streamlined processes and efficient content management has never been greater. In a new PharmaTimes Media Ltd article, Sonia A. Veluchamy, Our CEO, shares insights into how pharma’s regulatory strategies could hold valuable lessons for the #medicaldevice industry.   Discover how a proactive approach to regulatory information management (RIM) and leveraging automation can help optimize #compliance efforts.   🔗 Read the full article here: https://lnkd.in/gE69zhNP   #RegulatoryAffairs #MedicalDevices #Pharma #RIM #LifeSciences #MedTech #Automation

📅 Celegence will be attending and sponsoring the 𝐆𝐥𝐨𝐛𝐚𝐥 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐀𝐟𝐟𝐚𝐢𝐫𝐬 𝐒𝐮𝐦𝐦𝐢𝐭 (𝐆𝐏𝐑𝐀𝐒) from 22 – 24 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 2024 at the Sheraton Brussels Airport, Brussels. Join Hans van Bruggen, our Chief Scientific Officer, as he presents "𝐅𝐚𝐜𝐢𝐥𝐢𝐭𝐚𝐭𝐢𝐧𝐠 𝐭𝐡𝐞 𝐃𝐢𝐠𝐢𝐭𝐚𝐥 𝐓𝐫𝐚𝐧𝐬𝐟𝐨𝐫𝐦𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐌𝐨𝐝𝐮𝐥𝐞 3 𝐭𝐨 𝐏𝐐𝐂𝐌𝐂, 𝐈𝐃𝐌𝐏, 𝐚𝐧𝐝 𝐈𝐂𝐇 𝐌4𝐐 𝐑2" on Tuesday, 22 October at 9:40 - 10:10 CET. ➡️Learn more about our session here: https://lnkd.in/gr4Ef632 Visit us at 𝐁𝐨𝐨𝐭𝐡 3 to connect with our team, including Matt Tyler, Yusuf Azzeddine Leenen, Kosta Uzelac, CBAP, Hans van Bruggen and Rosal Khoury. 📖To learn more about our participation and what to expect at GPRAS 2024, read our blog: https://lnkd.in/gDuY3X3Q #GPRAS #GPRAS2024 #RegulatoryAffairs #GlobalSubmissions #IDMP #RIM #eSubmissions #Pharma #PharmaceuticalCompliance #RegulatoryCompliance

👏 A big thank you to everyone who joined us at the 10𝐭𝐡 𝐀𝐧𝐧𝐮𝐚𝐥 𝐌𝐚𝐬𝐭𝐞𝐫 𝐃𝐚𝐭𝐚 𝐚𝐧𝐝 𝐃𝐚𝐭𝐚 𝐆𝐨𝐯𝐞𝐫𝐧𝐚𝐧𝐜𝐞 𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐟𝐨𝐫 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬 𝐅𝐨𝐫𝐮𝐦! The conversations, insights, and collaborations made this event truly impactful. Our Celegence team - Hans van Bruggen, Rosal Khoury, and Sowmya Raju had a fantastic time connecting with fellow industry leaders, discussing challenges, and showcasing our cutting-edge solutions. The positive feedback on our hands-on demonstrations reinforced the growing demand for efficient and compliant data management processes in #lifesciences. We’re excited about the future of data governance and #regulatory innovation! If you want to learn more about how our solutions can help optimize your operations, reach out to us at info@celegence.com. #Pharmaceuticals #MasterDataManagement #MDM #DataGovernance #RegulatoryAffairs #Pharma #Compliance #DataQuality #Networking #DataManagement #Innovation

👏𝐀 𝐡𝐞𝐚𝐫𝐭𝐟𝐞𝐥𝐭 𝐭𝐡𝐚𝐧𝐤 𝐲𝐨𝐮 to all the delegates, industry leaders, solution providers, health authority representatives, and notified body experts who made last week’s Regulatory Affairs Professionals Society (RAPS) US #Convergence an outstanding success. Your collective insights on regulatory matters and best practices have truly elevated the #regulatoryaffairs landscape. We are thrilled with our participation and extend sincere appreciation to #RAPS for organizing such a remarkable event. The positive feedback we received, especially on our hands-on demos, fills us with pride. It was fantastic to see attendees gain a deeper understanding of our innovative software solutions, which are driving real change in #regulatory operations. 💡𝐌𝐢𝐬𝐬𝐞𝐝 𝐨𝐮𝐫 𝐥𝐢𝐯𝐞 𝐝𝐞𝐦𝐨𝐬? 𝐇𝐞𝐫𝐞’𝐬 𝐚 𝐪𝐮𝐢𝐜𝐤 𝐥𝐨𝐨𝐤 𝐚𝐭 𝐰𝐡𝐚𝐭 𝐰𝐞 𝐬𝐡𝐨𝐰𝐜𝐚𝐬𝐞𝐝: ➡𝐂𝐀𝐏𝐓𝐈𝐒™ - Streamlining the creation and automation of compliant MDR and IVDR documentation, ensuring faster, more efficient processes. Learn more here: https://lnkd.in/geq4tDHe ➡𝐃𝐨𝐬𝐬𝐩𝐥𝐨𝐫𝐞𝐫™ - Facilitating seamless sharing, viewing, and reviewing of eCTD, NeeS, and other dossier formats across regions and locations. Explore its capabilities here: https://lnkd.in/gUcDMfdt 📩 𝐑𝐞𝐚𝐜𝐡 𝐨𝐮𝐭 𝐭𝐨 𝐮𝐬 at info@celegence.com to explore how our cutting-edge solutions can enhance your regulatory operations. Thank you again to everyone who contributed to making this event a success! #RegulatoryCompliance #MDR #IVDR #RAPSConvergence #RAPS2024 #Pharma #RAPSUSConvergence #MedicalDevices #AI

Celegence recently collaborated with Regulatory Affairs Professionals Society (RAPS) on a comprehensive survey targeting Regulatory Affairs professionals in the #pharmaceutical industry. This survey explored current challenges, investment trends, technology adoption, processes, staffing, skillsets, and future outlooks to provide a holistic view of the industry's direction. 𝐆𝐫𝐞𝐚𝐭𝐞𝐬𝐭 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬: What are the most significant #regulatory challenges your organization is facing this year? ✔️𝐓𝐢𝐦𝐞 𝐚𝐧𝐝 𝐛𝐚𝐧𝐝𝐰𝐢𝐝𝐭𝐡 are the top challenges cited by pharmaceutical companies, with 45% of respondents identifying time as their primary issue.  ✔️𝐂𝐨𝐬𝐭 is another significant concern, mentioned by 31% of respondents.  ✔️𝐍𝐞𝐰 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐚𝐧𝐝 𝐬𝐭𝐚𝐟𝐟𝐢𝐧𝐠 also present major hurdles, noted by 27% and 26% respectively.    For C-suite respondents, 𝐭𝐢𝐦𝐞 𝐚𝐧𝐝 𝐬𝐭𝐚𝐟𝐟𝐢𝐧𝐠 are equally pressing, each cited by 42% of participants.     At Celegence, we understand these challenges and 𝐨𝐮𝐫 𝐀𝐈-𝐩𝐨𝐰𝐞𝐫𝐞𝐝 𝐞𝐱𝐩𝐞𝐫𝐭𝐬 𝐚𝐫𝐞 𝐡𝐞𝐫𝐞 𝐭𝐨 𝐬𝐮𝐩𝐩𝐨𝐫𝐭 𝐲𝐨𝐮 in navigating them efficiently. Let’s partner together to achieve your regulatory goals, streamline your processes and 4x your efficiency gains!     👉 Gain immediate access to the full survey to understand the key issues and challenges facing pharmaceutical companies in 2024: https://lnkd.in/gFbcm749      #Pharmaceuticals #RegulatoryAffairs #Compliance #RAPSSurvey #RAPS #Survey2024 #PharmaRegulations #RegulatoryCompliance