Celegence

🚨 𝐏𝐡𝐚𝐫𝐦𝐚 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐓𝐞𝐚𝐦𝐬, 𝐚𝐫𝐞 𝐲𝐨𝐮 𝐫𝐞𝐚𝐝𝐲 𝐟𝐨𝐫 𝐋𝐞𝐚𝐧 𝐀𝐮𝐭𝐡𝐨𝐫𝐢𝐧𝐠? On 𝐃𝐞𝐜𝐞𝐦𝐛𝐞𝐫 3𝐫𝐝, join Hans van Bruggen and Marloes van Bruggen - van der Geer as they break down how Lean Authoring can revolutionize your submission processes. ➡️ Secure your spot now: https://lnkd.in/gK87wzSy 𝐋𝐞𝐚𝐫𝐧 𝐡𝐨𝐰 𝐋𝐞𝐚𝐧 𝐀𝐮𝐭𝐡𝐨𝐫𝐢𝐧𝐠 𝐜𝐚𝐧: ✅ Streamline submissions  ✅ Save time with optimized document workflows  ✅ Ensure faster, clearer regulatory approvals Don’t miss this chance to improve your submission process. 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲! Learn more here: https://lnkd.in/guYiK2_w #regulatorycompliance #pharmaceuticals #submissionefficiency #Pharma #LeanAuthoring #regulatoryaffairs #pharma #eCTD 

Recently, Celegence celebrated its 6𝐭𝐡 Annual Day, 𝐀𝐢𝐤𝐲𝐚𝐦, in India, held at Bangalore! 🎉 Aikyam, meaning oneness, symbolizes the unity and shared spirit that have driven our growth and success. Over these six years, our journey has been marked by remarkable milestones, teamwork, and a collective drive to excel and innovate. 🌟 Reflecting on this celebration, we are reminded of the shared values and camaraderie that connect our teams across regions. The success we’ve achieved is a testament to the collaboration and passion of our talented team members, dedicated clients, and valued partners. Thank you for being an essential part of this journey. Here’s to many more years of growth, unity, and impact! 🌍✨ #Aikyam #6Years #CelebratingOneness #LifeSciences #RegulatoryConsulting #CelegenceAnnualDay #WeAreCelegence #TeamSuccess #TeamCelebration #CelegenceAwardsNight

🔍 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 𝐈𝐃𝐌𝐏 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐌𝐚𝐬𝐭𝐞𝐫 𝐃𝐚𝐭𝐚 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 (𝐌𝐃𝐌) In the #pharmaceutical industry, managing accurate and reliable data is critical. Master Data Management (MDM) plays a vital role in creating a single source of truth, essential for #IDMP (Identification of Medicinal Products) compliance. With MDM, organizations can ensure consistency across product information, reduce #compliance risks, and boost operational efficiency. In our latest blog, explore:  ✅ Key IDMP requirements and the role of MDM  ✅ Benefits of consolidating data across #drug development  ✅ How #MDM supports streamlined IDMP preparation and #regulatory readiness 📖 Read more: https://lnkd.in/gzXciTei At Celegence, we bring deep regulatory expertise and innovative tools like Dossplorer™ to simplify IDMP preparation and improve #data governance, empowering you to achieve compliance with confidence. Connect with us to learn how our team can support your IDMP journey: https://lnkd.in/g9bGxh6U #PharmaCompliance #DataManagement #RegulatoryAffairs #MasterData #MasterDataManagement #PharmaceuticalCompliance #AI #Pharma #HealthcareInnovation #regulatoryoperation #xEVMPD

𝐎𝐧 𝐛𝐞𝐡𝐚𝐥𝐟 𝐨𝐟 𝐞𝐯𝐞𝐫𝐲𝐨𝐧𝐞 𝐚𝐭 𝐂𝐞𝐥𝐞𝐠𝐞𝐧𝐜𝐞, 𝐰𝐞 𝐰𝐢𝐬𝐡 𝐲𝐨𝐮 𝐚 𝐣𝐨𝐲𝐨𝐮𝐬 𝐚𝐧𝐝 𝐬𝐩𝐚𝐫𝐤𝐥𝐢𝐧𝐠 𝐃𝐢𝐰𝐚𝐥𝐢! ✨ May this festival of lights bring new opportunities, prosperity, and happiness to you and your loved ones. As we celebrate, let’s continue to spread warmth and positivity in everything we do. Wishing you a festive season filled with joy, gratitude, and new beginnings. 🎉🤝 🪔 Happy Diwali! #HappyDiwali #FestivalOfLights #Diwali2024 #JoyAndProsperity #TeamCelegence #Deepavali #HappyDeepavali

𝐖𝐞 𝐚𝐫𝐞 𝐞𝐱𝐜𝐢𝐭𝐞𝐝 𝐭𝐨 𝐚𝐧𝐧𝐨𝐮𝐧𝐜𝐞 𝐭𝐡𝐞 𝐫𝐞𝐥𝐞𝐚𝐬𝐞 𝐨𝐟 𝐭𝐡𝐞 2024 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐑𝐞𝐩𝐨𝐫𝐭: 𝐌𝐚𝐧𝐚𝐠𝐢𝐧𝐠 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 & 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞! 🚀 In partnership with MedTech Intelligence, Celegence conducted an in-depth survey of 150 industry leaders to explore the current challenges, goals, and investment areas shaping the future of regulatory affairs in the #medicaldevice industry. Key insights from the report include: ✔️ 𝐓𝐨𝐩 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬: Time and bandwidth constraints were cited as the #1 challenge by 46% of regulatory professionals, with managing budgets closely behind at 44%.  ✔️ 𝐑𝐞𝐬𝐨𝐮𝐫𝐜𝐞 𝐋𝐢𝐦𝐢𝐭𝐚𝐭𝐢𝐨𝐧𝐬: A significant 79% of professionals report they don’t have the resources necessary to meet all 2024 priorities.  ✔️ 𝐌𝐃𝐑/𝐈𝐕𝐃𝐑 𝐈𝐧𝐯𝐞𝐬𝐭𝐦𝐞𝐧𝐭: Half of the respondents expect to increase their MDR/IVDR maintenance spending this year, highlighting the critical focus on compliance maintenance.  ✔️ 𝐀𝐈 𝐈𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧: Companies are cautiously moving toward AI integration, with early trials and proof-of-concepts underway to streamline compliance processes. 👉 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐫𝐞𝐩𝐨𝐫𝐭 𝐧𝐨𝐰 𝐭𝐨 𝐞𝐱𝐩𝐥𝐨𝐫𝐞 𝐭𝐡𝐞𝐬𝐞 𝐟𝐢𝐧𝐝𝐢𝐧𝐠𝐬 𝐚𝐧𝐝 𝐦𝐨𝐫𝐞: https://lnkd.in/gbyr8h4P A big thank you to everyone who participated and provided valuable insights for this report! Let’s continue to drive positive change in the industry together. #RegulatoryAffairs #MedicalDeviceIndustry #Compliance #MedTechInsights #Celegence #MedTechIntelligence #MDR #IVDR #LifeSciences #RegulatoryStrategy

📢 𝐋𝐚𝐬𝐭 𝐂𝐡𝐚𝐧𝐜𝐞 𝐭𝐨 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫! There’s only 24 hours left to register for our webinar, "𝐓𝐡𝐞 𝐀𝐫𝐭 𝐨𝐟 𝐁𝐞𝐧𝐞𝐟𝐢𝐭-𝐑𝐢𝐬𝐤 𝐂𝐚𝐥𝐜𝐮𝐥𝐚𝐭𝐢𝐨𝐧 – 𝐄𝐬𝐬𝐞𝐧𝐭𝐢𝐚𝐥 𝐓𝐨𝐨𝐥𝐬 𝐟𝐨𝐫 𝐄𝐔 𝐌𝐃𝐑 𝐌𝐚𝐬𝐭𝐞𝐫𝐲." 📅 𝐓𝐮𝐞𝐬𝐝𝐚𝐲, 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 29, 2024 | ⏰ 10:00 𝐀𝐌 𝐄𝐓 💡 Can’t make it live? Don’t worry – all registrants will receive access to the recording: https://lnkd.in/gK9imWP3  Learn the essential strategies and tools for accurate benefit-risk assessments under the EU MDR. For more insights on our session, read our webinar blog: https://lnkd.in/gkvxUJgu #MDR #BenefitRisk #MedicalDevices #Webinar #RegulatoryCompliance #HealthcareTech #MedTech #EUMDR #EUCompliance #Regulatory

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📚 𝐂𝐚𝐬𝐞 𝐒𝐭𝐮𝐝𝐲: 𝐀𝐜𝐡𝐢𝐞𝐯𝐢𝐧𝐠 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐰𝐢𝐭𝐡 𝐐𝐮𝐢𝐜𝐤 𝐂𝐄𝐑 𝐓𝐮𝐫𝐧𝐚𝐫𝐨𝐮𝐧𝐝 At Celegence, we’ve worked with #medicaldevice manufacturers around the globe to meet their Clinical Evaluation Report (CER) deadlines efficiently and effectively. Here’s how we supported a company to submit compliant CERs, saving them valuable time and resources. Here’s how we did it: ✅ Delivered CERs with minimal revisions  ✅ Used AI-powered literature review tools  ✅ Achieved a 99% first-time acceptance rate 👉 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐜𝐚𝐬𝐞 𝐬𝐭𝐮𝐝𝐲 here: https://lnkd.in/gFKykpim Let’s chat about how Celegence can help you meet your #CER deadlines. 📧 Get in touch: https://lnkd.in/g9bGxh6U #CaseStudy #MedicalDevices #MDR #CEP #RegulatoryCompliance #AI #RegulatoryAffairs #Clinical #EUMDR

🚀 𝐈𝐭’𝐬 𝐭𝐡𝐞 𝐟𝐢𝐧𝐚𝐥 𝐝𝐚𝐲 𝐨𝐟 #𝐆𝐏𝐑𝐀𝐒 2024! We’ve had an inspiring few days connecting with #regulatory professionals and sharing insights on how Celegence is reimagining compliance in the life sciences industry. But it’s not over yet! 👉 There’s still time to visit us at 𝐁𝐨𝐨𝐭𝐡 3 to explore our 𝐀𝐈-𝐩𝐨𝐰𝐞𝐫𝐞𝐝 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 and learn how we are revolutionizing #pharmaceutical regulatory affairs. 💡 Get hands-on demos of 𝐃𝐨𝐬𝐬𝐩𝐥𝐨𝐫𝐞𝐫™, our advanced cloud-based dossier management tool, designed to save time and resources for life sciences companies. Learn more about Dossplorer™ here: https://lnkd.in/equ8_S55.   Whether it’s #RIMS data management, global submissions, or strategic RA/QA support, our experts are here to help streamline your regulatory journey.   #GPRAS #GPRAS2024 #RegulatoryAffairs #PharmaceuticalCompliance #eSubmissions #IDMP #RIM #LifeSciences #GlobalSubmissions

💻 #𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐀𝐥𝐞𝐫𝐭 How can Lean Authoring streamline your #regulatory submissions and save time for your team? Join us on 𝐃𝐞𝐜𝐞𝐦𝐛𝐞𝐫 3𝐫𝐝 for the webinar “𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐢𝐧 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬: 𝐀𝐩𝐩𝐥𝐲 𝐭𝐡𝐞 𝐏𝐨𝐰𝐞𝐫 𝐨𝐟 𝐋𝐞𝐚𝐧 𝐀𝐮𝐭𝐡𝐨𝐫𝐢𝐧𝐠.” 📅 𝐃𝐚𝐭𝐞: December 3rd, 2024 | 🕒 𝐓𝐢𝐦𝐞: 10:00 AM ET 🎤 𝐒𝐩𝐞𝐚𝐤𝐞𝐫𝐬: Hans van Bruggen & Marloes van Bruggen - van der Geer In this webinar, you’ll gain insights into the Lean Authoring approach, which optimizes submission workflows, reduces document volume, and ensures faster regulatory approval. 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐎𝐛𝐣𝐞𝐜𝐭𝐢𝐯𝐞𝐬: ✅Understand the key principles of Lean Authoring  ✅Explore practical strategies for optimizing document authoring  ✅Discover best practices for faster global market access 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐍𝐨𝐰: https://lnkd.in/gK87wzSy Learn more about Lean Authoring webinar in our blog: https://lnkd.in/guYiK2_w  #regulatoryaffairs #regulatorycompliance #pharma #pharmaceuticals #leanauthoring #regulatoryapproval #submissionefficiency #webcast #lifesciences #eCTD