Celegence

At Celegence, we prioritize the well-being and #physicalwellness of our employees. The Celegence Fitness Fiesta was a fantastic way to promote these values through a fun-filled Fitness Month Challenge!   Congratulations to all the winners and participants for their outstanding performance. A special thank you to #VantageFit for their excellent technology support, making this challenge even more engaging and enjoyable.   #TeamWork #FitnessChallenge #EmployeeWellbeing #TeamBonding #CelegenceFitnessFiesta

🆕🔬 Expert Consulting Services for Laboratory Developed Tests (LDTs)!     Stay compliant with the latest #FDA regulations and streamline your LDT development with our comprehensive support. At Celegence, our team of seasoned professionals and industry experts possess the specialized knowledge necessary to ensure comprehensive #regulatory compliance for Laboratory Developed Tests (LDTs). Why Choose Celegence: ▶𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐆𝐮𝐢𝐝𝐚𝐧𝐜𝐞: Navigate FDA and CLIA standards with ease. ▶𝐏𝐡𝐚𝐬𝐞𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: Detailed plan for updating your QMS over the next three years. ▶𝐅𝐃𝐀 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬: Prepare for your LDT’s FDA submission in 2027 or 2028. 🎦 𝐖𝐚𝐭𝐜𝐡 𝐨𝐮𝐫 𝐈𝐧𝐭𝐫𝐨𝐝𝐮𝐜𝐭𝐢𝐨𝐧 𝐭𝐨 𝐋𝐃𝐓 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐕𝐢𝐝𝐞𝐨: https://lnkd.in/g76RwWnZ Explore our key services and solutions for LDTs and get in touch with us today.    #LDT #RegulatoryCompliance #MedicalDevices #HealthcareInnovation #QMS #USFDA #IVDR #IVD #LDTs #Diagnostics #DiagnosticTests #FDARegulations #LaboratoryDevelopedTest #LifeSciences #MedicalLabs

🎤 “𝐂𝐞𝐥𝐞𝐠𝐞𝐧𝐜𝐞'𝐬 𝐔𝐒𝐅𝐃𝐀 𝐬𝐞𝐫𝐯𝐢𝐜𝐞𝐬 𝐚𝐫𝐞 𝐭𝐚𝐢𝐥𝐨𝐫𝐞𝐝 𝐭𝐨 𝐦𝐞𝐞𝐭 𝐭𝐡𝐞 𝐝𝐢𝐯𝐞𝐫𝐬𝐞 𝐧𝐞𝐞𝐝𝐬 𝐨𝐟 𝐨𝐮𝐫 𝐜𝐥𝐢𝐞𝐧𝐭𝐬” Hear from Joy Greidanus, Director - Medical Device SME, as she shares how Celegence supports regulatory pathway planning, device listings, registrations, submission strategies, and development across various FDA pathways. 𝐖𝐡𝐲 𝐂𝐡𝐨𝐨𝐬𝐞 𝐂𝐞𝐥𝐞𝐠𝐞𝐧𝐜𝐞? ▶𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐏𝐚𝐭𝐡𝐰𝐚𝐲 𝐏𝐥𝐚𝐧𝐧𝐢𝐧𝐠: Comprehensive support for planning and navigating regulatory pathways. ▶𝐃𝐞𝐯𝐢𝐜𝐞 𝐋𝐢𝐬𝐭𝐢𝐧𝐠𝐬 & 𝐑𝐞𝐠𝐢𝐬𝐭𝐫𝐚𝐭𝐢𝐨𝐧𝐬: Efficient handling of device listings and registrations to meet USFDA requirements.  ▶𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐒𝐮𝐩𝐩𝐨𝐫𝐭: Assistance with development across FDA pathways like de novo investigational device exemptions and emergency use authorizations. 🌟 Ensure compliance and accelerate time to market with Celegence’s USFDA services. Need expert regulatory support? Get in touch with Celegence today: https://lnkd.in/g9bGxh6U #RegulatoryServices #LifeSciences #Pharmaceuticals #MedicalDevices #Celegence #USFDA #RegulatoryPathways #Compliance #MarketAccess 

🔍 𝐒𝐞𝐞𝐤𝐢𝐧𝐠 𝐚 𝐝𝐞𝐞𝐩 𝐝𝐢𝐯𝐞 𝐢𝐧𝐭𝐨 𝐠𝐥𝐨𝐛𝐚𝐥 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐭𝐡𝐞 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲? Our webinar on "𝐌𝐚𝐧𝐚𝐠𝐢𝐧𝐠 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐚𝐧𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 𝐀𝐬𝐬𝐞𝐬𝐬𝐢𝐧𝐠 𝐒𝐭𝐚𝐭𝐮𝐬, 𝐆𝐚𝐩𝐬, 𝐚𝐧𝐝 𝐍𝐞𝐞𝐝𝐬" is just around the corner! Join us on July 31, 2024 at 12 PM ET for an in-depth discussion with regulatory industry and notified body experts. The panel discussion will explore the latest survey data on regulatory strategy, compliance management, and MDR/IVDR maintenance. Gain valuable insights into current technologies, essential resources, and effective regulatory cost management practices. ⌛ Secure your spot today and ensure your organization stays ahead in #regulatorycompliance. Register here: https://lnkd.in/gX8g33mW MedTech Intelligence, SGS, Dr. Pratibha Mishra, Erin Cosgrove, Ibim Tariah, Gregory Jacobson and Rich West. #MedTech #Webinar #RegulatoryStrategy #MedicalDevices #MDR #IVDR #RegulatoryIntelligence #Regulatory #RegulatoryAffairs

Regulatory fatigue...a concern voiced in recent MTI audience polling, and an issue we're hearing more and more medical device regulatory affairs teams voice. Join our panel of regulatory SMEs as they unpack recent survey data on regulatory strategy, compliance management, and MDR/IVDR maintenance, plus insights into current technologies, resources and regulatory cost management. https://lnkd.in/gX8g33mW Celegence SGS Punya Abbhi Dr. Pratibha Mishra Erin Cosgrove Ibim Tariah, Gregory Jacobson Rich West

𝐒𝐞𝐞𝐤𝐢𝐧𝐠 𝐞𝐂𝐓𝐃 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐠𝐮𝐢𝐝𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐫𝐞𝐠𝐢𝐨𝐧-𝐬𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐛𝐨𝐝𝐢𝐞𝐬?🌍 Efficiently managing #regulatory submissions is crucial for pharmaceutical companies, and eCTD Module 1 is a key component. Our latest blog provides an in-depth guide to help you navigate #eCTD Module 1, ensuring smooth and compliant submissions. 📰 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐠𝐮𝐢𝐝𝐞: https://lnkd.in/gXB7Q2Y6 𝐈𝐧 𝐭𝐡𝐢𝐬 𝐛𝐥𝐨𝐠, 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐝𝐢𝐬𝐜𝐨𝐯𝐞𝐫:  ✅ Detailed overview of eCTD Module 1  ✅ Common challenges and solutions  ✅ Best practices for ensuring compliance  ✅ Tips for a successful submission process 𝐍𝐞𝐞𝐝 𝐞𝐱𝐩𝐞𝐫𝐭 𝐬𝐮𝐩𝐩𝐨𝐫𝐭 𝐢𝐧 𝐲𝐨𝐮𝐫 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐣𝐨𝐮𝐫𝐧𝐞𝐲? 🤝 𝐂𝐞𝐥𝐞𝐠𝐞𝐧𝐜𝐞 𝐢𝐬 𝐡𝐞𝐫𝐞 𝐭𝐨 𝐚𝐬𝐬𝐢𝐬𝐭 𝐲𝐨𝐮! Discover how we help you achieve #compliance excellence, reduce compliance costs, and streamline submission processes, with our expert team and innovative AI-enabled solutions: https://lnkd.in/g9bGxh6U #Pharmaceuticals #FDA #EMA #RegulatoryCompliance #PharmaIndustry #RegulatoryPublishing #RegulatorySubmissions

🎤 “𝐖𝐞 𝐩𝐫𝐨𝐯𝐢𝐝𝐞 𝐫𝐞𝐥𝐢𝐚𝐛𝐥𝐞, 𝐟𝐚𝐬𝐭 𝐚𝐧𝐝 𝐡𝐢𝐠𝐡 𝐑𝐎𝐈 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐭𝐡𝐞 𝐬𝐞𝐚𝐦𝐥𝐞𝐬𝐬 𝐢𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐩𝐞𝐨𝐩𝐥𝐞, 𝐩𝐫𝐨𝐜𝐞𝐬𝐬 𝐚𝐧𝐝 𝐭𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲.” Hear from Lakshmeenarayana Goundalkar (LGG), Chief Delivery Officer of Regulatory Services, as he shares how Celegence’s expertise delivers reliable, fast, and high ROI regulatory services through the seamless integration of people, process, and technology. 𝐖𝐡𝐲 𝐂𝐡𝐨𝐨𝐬𝐞 𝐂𝐞𝐥𝐞𝐠𝐞𝐧𝐜𝐞? ▶𝐄𝐱𝐩𝐞𝐫𝐭 𝐓𝐞𝐚𝐦: Benefit from the extensive regulatory knowledge of our diverse talents and subject matter experts. ▶𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐞𝐝 𝐏𝐫𝐨𝐜𝐞𝐬𝐬𝐞𝐬: Enjoy accuracy and adherence to regulatory requirements with our robust processes.  ▶𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐯𝐞 𝐓𝐞𝐜𝐡𝐧𝐨𝐥𝐨𝐠𝐲: Leverage our continual investment in automation and cutting-edge technology to stay ahead of industry trends. Transform your regulatory experience with Celegence’s innovative solutions today: https://lnkd.in/g9bGxh6U #RegulatoryServices #LifeSciences #Innovation #Technology #Celegence #RegulatorySolutions #HighROI #RegulatoryCompliance #Automation #Medtech #Pharma #Pharmaceuticals

𝐔𝐩𝐜𝐨𝐦𝐢𝐧𝐠 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐖𝐞𝐛𝐢𝐧𝐚𝐫! Join us for an exclusive data-driven webinar in partnership with MedTech Intelligence. “𝐌𝐚𝐧𝐚𝐠𝐢𝐧𝐠 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐚𝐧𝐝 𝐂𝐨𝐦𝐩𝐥𝐢𝐚𝐧𝐜𝐞: 𝐀𝐬𝐬𝐞𝐬𝐬𝐢𝐧𝐠 𝐒𝐭𝐚𝐭𝐮𝐬, 𝐆𝐚𝐩𝐬, 𝐚𝐧𝐝 𝐍𝐞𝐞𝐝𝐬” Join our panel of notified bodies, regulatory management & maintenance experts, as they explore key insights and results from a recent industry survey on enhancing regulatory intelligence and addressing compliance gaps in the medical device industry. 📅 July 31, 2024 | 🕙 12:00 PM ET US ✍ 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐍𝐨𝐰: https://lnkd.in/gX8g33mW 𝐋𝐞𝐚𝐫𝐧𝐢𝐧𝐠 𝐨𝐛𝐣𝐞𝐜𝐭𝐢𝐯𝐞𝐬: ▶Recognize why the gaps in your regulatory intelligence and compliance processes are overwhelming you, your team and your organization.  ▶How to mitigate the risks in the growing complexities of global regulatory compliance.  ▶Where to focus MDR/IVDR priorities and investment.  ▶Technologies and resources for cost-effective management of current bandwidth limitations being experienced across the industry. Don’t miss this opportunity to learn from industry leaders! Dive deeper into the webinar topic and meet our expert speaker Dr. Pratibha Mishra here: https://lnkd.in/g26vFDiu #MedTech #Webinar #RegulatoryCompliance #MedicalDevices #MDR #IVDR #RegulatoryIntelligence #Regulatory #RegulatoryAffairs

⏰ 24 Hour Reminder! Join us tomorrow, 10 - 11 AM Eastern Time, for our #Webinar on Regulatory Affairs Leadership Perspectives – 2024 Survey Insights. 👉 Register Now: https://lnkd.in/g42XTbQH  Don’t miss out on insights from the life sciences survey and practical knowledge from Sonia A. Veluchamy and Punya Abbhi. For more information, visit: https://lnkd.in/gSyjQvE8 #RegulatoryAffairs #Pharma #MedicalDevices #AI #Webinar #Compliance #Pharmaceuticals #RAPS #RAPSSurvey2024 #DossierManagement #RegulatoryCompliance

📘Your Comprehensive Guide to Drug Master Files (DMF) Submission! Mastering the complexities of Drug Master Files (DMF) is essential for ensuring #compliance and smooth submissions. Our latest blog offers valuable tips and best practices for successful DMF submissions, tailored to help #pharmaceutical companies achieve #regulatory success. In this blog, you will learn: ▶ Key components of a DMF  ▶ Common challenges in DMF submissions  ▶ Best practices for ensuring compliance  ▶ Tips for a smooth submission process 📚 𝐑𝐞𝐚𝐝 𝐭𝐡𝐞 𝐟𝐮𝐥𝐥 𝐛𝐥𝐨𝐠 𝐡𝐞𝐫𝐞: https://lnkd.in/gjqgP6-F 🔍 𝐋𝐨𝐨𝐤𝐢𝐧𝐠 𝐟𝐨𝐫 𝐞𝐱𝐩𝐞𝐫𝐭 𝐬𝐮𝐩𝐩𝐨𝐫𝐭 𝐢𝐧 𝐲𝐨𝐮𝐫 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐬𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐣𝐨𝐮𝐫𝐧𝐞𝐲? Celegence is here to help. Discover how we can assist you in achieving compliance excellence: https://lnkd.in/g9bGxh6U #Pharmaceuticals #DrugMasterFiles #DMF #RegulatoryCompliance #PharmaIndustry #ComplianceExcellence #RegulatorySubmission