?? Countdown Alert! Just two weeks to go for our ???? ?????? ???????????????????? ?????? ???????????????????? ???????????????????? webinar on December 5th. Gain insights on using AI for efficient #regulatory data management in #medicaldevices. Learning Highlights: ?Explore smart tools for technical #dossier management? ?Benefits of AI in regulatory documentation ?Best practices for #clinical data presentation ?? Register here: https://lnkd.in/g4yQajBY? For more insights on our session, read our webinar blog: https://lnkd.in/gErvqJNz #RegulatoryCompliance #AI #MedicalDevice #MedTech #Automation #HealthcareInnovation #AIinHealthcare #RegulatoryAffairs #MDR #IVDR
Celegence
商务咨询服务
Downers Grove，Illinois 12,227 位关注者
Global Regulatory Affairs Services & Technology for the Life Sciences Industry.
关于我们
Celegence provides services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy. We aim to help Life Sciences companies navigate complex global regulatory requirements by providing depth of experience and an extensive delivery capability. As regulatory specialists, we work across all phases of the product lifecycle from regulatory strategy, authoring, and all aspects of established product maintenance, including submission management, publishing and health authority interaction. We leverage a global team of consultants to provide local regulatory insight, strategy and intelligence. Our mission is to collaborate with our customers to deliver Regulatory Affairs efficiency that allows them to focus on what matters most: providing exceptional patient value. We support companies in ensuring regulatory compliance across the globe by providing fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day-to-day operations. Celegence is a privately owned business headquartered in Chicago, IL with offices in the U.K., Europe, and Bangalore(India).
- 网站
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https://www.celegence.com
Celegence的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 51-200 人
- 总部
- Downers Grove，Illinois
- 类型
- 私人持股
- 创立
- 2017
地点
Celegence员工
动态
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As regulatory compliance becomes more complex, companies are prioritizing investment in MDR/IVDR maintenance. Our recent survey with MedTech Intelligence highlights how #medicaldevice leaders are addressing the financial and resource demands of ongoing regulatory compliance. Key insights:?? ??Increased Investment – 50% plan to increase MDR/IVDR maintenance spending? ??Growth in Spending – Nearly a third expect a rise of over 10% from last year Celegence can help you manage MDR/IVDR costs more efficiently with AI-driven solutions. Let’s connect to discuss your #regulatory needs. ?? Gain immediate access to the full survey: https://lnkd.in/gbyr8h4P #MDR #IVDR #Compliance #MedicalDevices #MedTechInsights?#EUMDR #EUIVDR #MedTech #RegulatoryAffairs #RegulatoryCompliance #AI #MedTechSurvey
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?? 2 Weeks Left to Register for the Lean Authoring Webinar! Ready to speed up your submission timelines and reduce document complexity? Join our webinar on December 3rd to explore Lean Authoring techniques. ?? Date: December 3rd, 2024 | ?? Time: 10:00 AM ET ?? Speakers: Hans van Bruggen & Marloes van Bruggen - van der Geer ??? Can't attend live? All registrants will receive the webinar recording. What You'll Learn: ? Lean Authoring vs. traditional formats? ? Optimizing document authoring for better data reuse? ? Best practices for faster market access ???????????????? ??????: https://lnkd.in/gK87wzSy For more details, visit our blog: https://lnkd.in/guYiK2_w #regulatoryaffairs #pharma #submissionefficiency #webinar #compliance #LeanAuthoring #regulatorycompliance #pharmaceuticals
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Streamlining SFDA Approval for Class C #MedicalDevices in Saudi Arabia Discover how Celegence enabled seamless #regulatory authorization for a complex laparoscopic device system, achieving swift approval from the Saudi Food and Drug Authority (SFDA). Our team provided a comprehensive solution to meet Saudi Arabia's stringent medical device regulations: ? Technical Documentation: Assembled and authored a compliant #TechnicalFile for submission.? ? Safety & Performance:?Created an Essential Principles Checklist with evidence of standards #compliance.? ? Streamlined Submission: Developed 18 technical file subdocuments for KSA’s Unified Electronic System (GHAD). ?? Full Case Study Here: https://lnkd.in/gQWffkGi Celegence’s regulatory expertise ensured efficient compliance, delivering regulatory approval on time. ?? Looking to navigate complex regulatory approvals? Contact us to learn more: https://lnkd.in/g9bGxh6U #MedicalDevice #SFDA #RegulatoryCompliance #Celegence #MedTech #SuccessStory #RegulatoryAffairs
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Grateful to Karen Jagoda and the Empowered Patient podcast for an insightful conversation with our CEO and Co-Founder, Sonia A. Veluchamy. Sonia shared some powerful insights on how medical device companies can thrive amid rising regulatory demands, exploring smart ways to boost efficiency and stay ahead. ? Catch the full episode to hear how Celegence is supporting the industry with innovative solutions for regulatory success - https://lnkd.in/gP2Bs4uv or hear this on Spotify - https://lnkd.in/gXPrs3Yb ? #MedicalDeviceInnovation #RegulatoryExcellence #AIinHealthcare #AI #MedicalDeviceEfficiency?#RegulatoryAffairs
#transcript Sonia Veluchamy, CEO and Co-founder of Celegence discusses the increasing regulatory requirements and complexities faced by the medical device industry. Celegence works with companies to streamline their regulatory data management processes and adopt advanced technology solutions to manage compliance efficiently. Medical device companies are often slower than pharmaceutical companies to recognize the need to invest in data governance and process optimization to maintain compliance and avoid fines, delays in product approval, and loss of market access. #Celegence #RegulatoryAffairs #RegTech #RegulatoryStrategy #Pharmaceuticals celegence.com https://lnkd.in/gcCbYDbJ
Increasing Focus of Medical Device Companies on Regulations and Compliance with Sonia Veluchamy Celegence TRANSCRIPT
empoweredpatientradio.com
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We're #hiring a new Medical Writer in Greater Bengaluru Area. Apply today or share this post with your network.
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?? Compliance complexity slowing you down? Join us on December 5th for ???? ?????? ???????????????????? ?????? ???????????????????? ???????????????????? ???? ?????????????? ?????????????? webinar to explore how AI can simplify your regulatory data management. In this session, Celegence experts Shruti Sharma and Joseph-Richardson Larbi, MSc RA - Medical Devices will cover: ?Efficient use of AI tools in dossier management ?How AI supports accurate data for competent authorities? ?Best practices for presenting clinical data effectively ?? Reserve your spot: https://lnkd.in/g4yQajBY? Learn more about the session in our webinar blog: https://lnkd.in/gErvqJNz #RegulatoryCompliance #AI #MedicalDevice #MedTech #Automation #HealthcareInnovation #AIinHealthcare #RegulatoryAffairs #MDR #IVDR
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Understanding Ad/Promo Submissions to the FDA: Process, Transition, and Compliance with eCTD For pharmaceutical companies, ensuring #FDA compliance for advertising and promotional (Ad/Promo) materials is essential to effective product marketing. With the transition to #eCTD submissions, managing these requirements is now more streamlined, efficient, and compliant. Our latest blog covers: ? What Ad/Promo submissions are and why they matter ? Key steps in the FDA’s eCTD submission process ? Advantages and challenges of transitioning to eCTD ?? Read more: https://lnkd.in/gPSyU74D As experts in #regulatory submissions, Celegence supports Life Sciences companies with end-to-end Ad/Promo submission management, ensuring compliance with FDA’s eCTD format. Ready to optimize your regulatory operations? Reach out to us: https://lnkd.in/g9bGxh6U #AdPromo #RegulatoryCompliance #PharmaIndustry #CTD #Pharma #RegulatorySubmission #Compliance #RegulatoryAffairs #RegTech #USFDA #Pharmaceuticals
Ad/Promo Submissions to the FDA: Compliance with eCTD
https://www.celegence.com
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With increasing global #regulations, resource strain is becoming a common challenge across the industry. Celegence and MedTech Intelligence conducted a survey of regulatory affairs professionals in the #medicaldevice sector, uncovering the impact of bandwidth and resource constraints on #regulatory teams. The findings reveal that:?? ?? Bandwidth – Cited as the #1 challenge by over a quarter of respondents? ?? Resource Gaps – 79% report they lack resources for all 2024 priorities 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 medical device companies: https://lnkd.in/gbyr8h4P #RegulatoryAffairs #MedicalDeviceIndustry #Compliance #MDR #IVDR #MedTechInsights #RegulatoryStrategy #Celegence #MedTechIntelligence #AIinHealthCare #MedTech #MedicalDeviceRegulation #MedTechSurvey
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??Experience CAPTIS?: The AI-Powered Solution Revolutionizing Regulatory Workflows For medical device manufacturers and clinical evaluation teams, managing complex #regulatory requirements like the EU #MDR and EU #IVDR can be challenging. At Celegence, our subject matter experts leverage CAPTIS?, an advanced platform that streamlines regulatory tasks, reduces risks, and maintains #compliance with precision. Explore this video as our #medicalwriting team shares firsthand how CAPTIS drives impactful results:? ? AI-Driven Efficiency - Automates repetitive tasks, allowing teams to focus on critical activities? ?Consistency and Accuracy - Maintains accuracy across documents with automated consistency checks? ?Simplified Literature Review - Quickly identifies essential study details like demographics and outcomes? ? Centralized Resources - Supports seamless collaboration and traceability ? Whether it’s generating PRISMA flowcharts or linking literature databases seamlessly, CAPTIS equips Celegence teams to deliver compliance excellence across complex projects for our clients. ?? Discover how CAPTIS? can reduce manual efforts and save your team valuable time. Schedule a free demo today: https://lnkd.in/dsphugc3 #RegulatoryAffairs #MedicalDevices #AIPowered #MedicalWriting #AI #ClinicalEvaluation #EUMDR #EUIVDR #MedicalDeviceRegulations #MedTech #Clinical #AutomationInRegulatory #LifeSciencesTech #MarketAccess #DocumentManagement #RegulatoryCompliance