regenold GmbH

Das Event der dtXca mit The Health Club House bietet exklusive Einblicke in die aktuellen Entwicklungen und Herausforderungen des DiGA-Marktes. Ein wertvoller Austausch mit Perspektiven für die Zukunft. Die Plätze sind begrenzt – jetzt registrieren! 👇

𝗪𝗲 𝗮𝗿𝗲 𝗲𝘅𝗰𝗶𝘁𝗲𝗱 𝘁𝗼 𝗮𝗻𝗻𝗼𝘂𝗻𝗰𝗲 𝘁𝗵𝗮𝘁 regenold GmbH 𝗵𝗮𝘀 𝗽𝗿𝗼𝘂𝗱𝗹𝘆 𝗷𝗼𝗶𝗻𝗲𝗱 𝘁𝗵𝗲 Medtech & Pharma Platform Association! At regenold, we have longstanding expertise and a deep commitment to all aspects of 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀, from cross-labelled and co-packaged drug-device combinations to in vitro diagnostic (IVD) solutions and connected technologies. Becoming part of the MPP community reinforces our dedication to shaping the future of innovation in this vital, cross-sectoral field. The MPP Association is a cross-sectoral industry association bringing together pharmaceutical, medtech, diagnostic, and tech companies. Established in 2017, it focuses on 𝗰𝗼𝗺𝗯𝗶𝗻𝗲𝗱 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀—any use of a medicinal product (including biologics and ATMPs) with a device or diagnostic. With a geographical focus on Europe, the MPP closely tracks and engages with regulatory and policy developments for pharmaceuticals, medical devices/IVDs, and technology products. 𝗪𝗵𝘆 𝗠𝗣𝗣 𝗠𝗮𝘁𝘁𝗲𝗿𝘀 • 𝗦𝘆𝗻𝗲𝗿𝗴𝗶𝗲𝘀: Enhance collaboration between pharma, medtech, diagnostics, and tech. • 𝗡𝗲𝘄 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻 𝗠𝗼𝗱𝗲𝗹𝘀: Accelerate market access for safe and innovative treatment options. • 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗙𝗿𝗮𝗺𝗲𝘄𝗼𝗿𝗸: Support a policy environment that fosters progress and addresses the complexities of combined products. Through multiple working groups—covering everything from co-packaged drug-device combinations and the requirements of Article 117 MDR, to AI, cybersecurity, IVDs/CDx, and beyond—the MPP tackles the 𝗸𝗲𝘆 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 and 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 facing combination product innovation. 𝗔𝗰𝘁𝗶𝘃𝗶𝘁𝗶𝗲𝘀 & 𝗔𝗱𝘃𝗼𝗰𝗮𝗰𝘆 The MPP drives 𝘀𝘁𝗮𝗸𝗲𝗵𝗼𝗹𝗱𝗲𝗿 𝗱𝗶𝗮𝗹𝗼𝗴𝘂𝗲 at the EU level, actively contributes to public consultations, and maintains close relationships with other European trade associations. Its specialized events provide 𝗰𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 on the latest regulatory and legislative trends related to combined products, medicinal products, medical devices, and IVDs. 𝗢𝘂𝗿 𝗡𝗲𝘅𝘁 𝗦𝘁𝗲𝗽𝘀 At regenold GmbH, we look forward to 𝗮𝗰𝘁𝗶𝘃𝗲𝗹𝘆 𝗽𝗮𝗿𝘁𝗶𝗰𝗶𝗽𝗮𝘁𝗶𝗻𝗴 in the MPP’s working groups and events, contributing our expertise to help shape the evolving regulatory and policy landscape for combination products. 𝗪𝗚 𝗼𝗻 𝗰𝗼𝗻𝗻𝗲𝗰𝘁𝗲𝗱 𝗰𝗼𝗺𝗯𝗶𝗻𝗲𝗱 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 ➔ Oliver Hilgers 𝗪𝗚 𝗼𝗻 𝗜𝗩𝗗𝘀 ➔ Tobias Bartl 𝗪𝗚 𝗼𝗻 𝗰𝗼𝗺𝗯𝗶𝗻𝗲𝗱 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 ➔ Felix Metzner We believe this collaboration will bring significant value to our clients, patients, and partners, ensuring access to 𝘀𝗮𝗳𝗲𝗿, 𝗺𝗼𝗿𝗲 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲, and 𝗲𝗳𝗳𝗶𝗰𝗶𝗲𝗻𝘁 𝗵𝗲𝗮𝗹𝘁𝗵𝗰𝗮𝗿𝗲 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀. #CombinationProducts, #MedicalDevices, #MedTech, #DrugDelivery, #HealthcareInnovation

🚀 𝗚𝗿𝗼ß𝗲 𝗡𝗲𝘂𝗶𝗴𝗸𝗲𝗶𝘁𝗲𝗻 𝗳𝘂𝗿 𝗱𝗶𝗲 𝗗𝗧𝘅 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻𝘀𝘀𝗰𝗵𝗶𝗲𝗻𝗲: @𝗿𝗲𝗴𝗲𝗻𝗼𝗹𝗱 𝗚𝗺𝗯𝗛 𝗸𝗼𝗼𝗽𝗲𝗿𝗶𝗲𝗿𝘁 @𝗢𝗛𝗔! Wir bei der regenold GmbH freuen uns sehr, unsere eigentlich schon bestehende Partnerschaft mit dem OHA Osnabrück Healthcare Accelerator nun auch offiziell bekanntzugeben! Diese Zusammenarbeit markiert einen weiteren Meilenstein in unserer Mission, Innovationen im Gesundheitswesen effizient auf den Markt zu bringen und Startups sowie etablierte Unternehmen bei regulatorischen Herausforderungen zu unterstützen. 𝗪𝗮𝗿𝘂𝗺 𝗶𝘀𝘁 𝗱𝗮𝘀 𝘄𝗶𝗰𝗵𝘁𝗶𝗴? Der OHA ist ein führender Accelerator im Bereich Digital Health und Medtech, der Startups mit einem starken Netzwerk aus über 60 Partnern und 40 Alumni-Startups unterstützt. Durch unsere Partnerschaft können wir gemeinsam Startups dabei helfen, regulatorische Hürden schneller zu meistern und ihre bahnbrechenden Ideen in marktfähige Lösungen zu verwandeln. 𝗪𝗮𝘀 𝗯𝗿𝗶𝗻𝗴𝘁 𝗿𝗲𝗴𝗲𝗻𝗼𝗹𝗱 𝗶𝗻 𝗱𝗶𝗲𝘀𝗲 𝗣𝗮𝗿𝘁𝗻𝗲𝗿𝘀𝗰𝗵𝗮𝗳𝘁 𝗲𝗶𝗻? Seit 1994 begleiten wir Unternehmen weltweit in über 90 Ländern bei der Entwicklung, Zulassung und dem Marktzugang von Arzneimitteln und Medizinprodukten. Unsere Expertise umfasst: • 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝗶𝘀𝗰𝗵𝗲 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝗻 & 𝗨𝗺𝘀𝗲𝘁𝘇𝘂𝗻𝗴 • 𝗣𝗵𝗮𝗿𝗺𝗮𝘇𝗲𝘂𝘁𝗶𝘀𝗰𝗵𝗲 & 𝗸𝗹𝗶𝗻𝗶𝘀𝗰𝗵𝗲 𝗘𝗻𝘁𝘄𝗶𝗰𝗸𝗹𝘂𝗻𝗴 • 𝗠𝗮𝗿𝗸𝘁𝘇𝘂𝗴𝗮𝗻𝗴𝘀- 𝘂𝗻𝗱 𝗘𝗿𝘀𝘁𝗮𝘁𝘁𝘂𝗻𝗴𝘀𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝗶𝗲𝗻 • 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 (𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗔𝗽𝗽𝘀, 𝗣𝗶𝗹𝗹 𝗽𝗹𝘂𝘀 𝗗𝗧𝘅, 𝗗𝗶𝗚𝗔, 𝗗𝗶𝗣𝗔) • 𝗜𝗻𝘃𝗲𝗿𝗸𝗲𝗵𝗿𝗯𝗿𝗶𝗻𝗴𝘂𝗻𝗴 𝘃𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗸𝘁𝗲𝗻 𝗮𝗹𝘀 𝗦𝗲𝗿𝘃𝗶𝗰𝗲 (𝗟𝗠 𝗦𝗲𝗿𝘃𝗶𝗰𝗲) Besonders im Bereich Digital Health sind wir stolz darauf, als Gamechanger Innovationen voranzutreiben – von der Idee bis zur Zulassung und darüber hinaus. 𝗚𝗲𝗺𝗲𝗶𝗻𝘀𝗮𝗺 𝗳𝘂𝗿 𝗲𝗶𝗻𝗲 𝗯𝗲𝘀𝘀𝗲𝗿𝗲 𝗭𝘂𝗸𝘂𝗻𝗳𝘁 𝗶𝗺 𝗚𝗲𝘀𝘂𝗻𝗱𝗵𝗲𝗶𝘁𝘀𝘄𝗲𝘀𝗲𝗻 Diese Partnerschaft ist mehr als nur eine Zusammenarbeit und eint den Wunsch Innovationen im Gesundheitswesen zu schaffen. Wir freuen uns auf spannende Projekte, neue Visionen und darauf, gemeinsam die Zukunft der Gesundheitstechnologien zu gestalten. 👉 𝗟𝗮𝘀𝘀𝘁 𝘂𝗻𝘀 𝘇𝘂𝘀𝗮𝗺𝗺𝗲𝗻 𝗚𝗿𝗼ß𝗲𝘀 𝗯𝗲𝘄𝗲𝗴𝗲𝗻!  #𝗗𝗶𝗴𝗶𝘁𝗮𝗹𝗛𝗲𝗮𝗹𝘁𝗵 #𝗠𝗲𝗱𝗧𝗲𝗰𝗵 #𝗛𝗲𝗮𝗹𝘁𝗵𝗧𝗲𝗰𝗵 #𝗗𝗧𝘅 #𝗱𝘁𝘅𝗰𝗮

𝗿𝗲𝗴𝗲𝗻𝗼𝗹𝗱 𝗚𝗺𝗯𝗛 & 𝗖𝗮𝗿𝗲𝗺𝗮𝘁𝗶𝘅 𝗮𝘁 𝗦𝗖𝗢𝗣𝗘 𝗦𝘂𝗺𝗺𝗶𝘁 𝟮𝟬𝟮𝟱! 🚀 We’re excited to announce that regenold GmbH and Carematix Inc. are teaming up once again at the 𝗦𝗖𝗢𝗣𝗘 𝗦𝘂𝗺𝗺𝗶𝘁 𝟮𝟬𝟮𝟱 in 𝗢𝗿𝗹𝗮𝗻𝗱𝗼, 𝗙𝗲𝗯𝗿𝘂𝗮𝗿𝘆 𝟯-𝟲! Under the theme “𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗠𝗲𝗲𝘁𝘀 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻,” we’ll be showcasing our combined solutions for digital health applications as well as our 𝗖𝗹𝗶𝗻𝗦𝗲𝗻𝘀𝗲𝗧𝗠 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁 𝗗𝗶𝗴𝗶𝘁𝗮𝗹 𝗛𝗲𝗮𝗹𝘁𝗵 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 (𝗗𝗛𝗧𝗦) 𝗮𝗻𝗱 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀—an integrated suite of end-to-end solutions designed to bridge the gap between cutting-edge digital health innovations and global regulatory compliance. 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴: 𝗖𝗹𝗶𝗻𝗦𝗲𝗻𝘀𝗲™ 🌟 𝗖𝗹𝗶𝗻𝗦𝗲𝗻𝘀𝗲𝗤𝗠𝗦™ – A compliant, medical-grade Quality Management System (QMS) 🌟 𝗖𝗹𝗶𝗻𝗦𝗲𝗻𝘀𝗲𝗗𝗕™ – A compliant, regulatory-cleared, cloud-based database 🌟 𝗖𝗹𝗶𝗻𝗦𝗲𝗻𝘀𝗲 𝗘𝗻𝗱𝗽𝗼𝗶𝗻𝘁 𝗟𝗶𝗯𝗿𝗮𝗿𝘆™ – A collection of validated and experimental digital endpoints for seamless integration 🌟 𝗖𝗹𝗶𝗻𝗦𝗲𝗻𝘀𝗲 𝗦𝗶𝗺𝘂𝗹𝗮𝘁𝗲™ – Proprietary AI/ML aiHumanoid/Virtual Human Twin Platform 🔬 𝗖𝗹𝗶𝗻𝗦𝗲𝗻𝘀𝗲 𝗦𝗶𝗺𝘂𝗹𝗮𝘁𝗲™ replicates real-world human responses with 95% confidence, helping reduce the risk of pursuing ineffective products. By integrating our 𝗽𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗮𝗻𝗱 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘀𝗲𝗿𝘃𝗶𝗰𝗲𝘀, we can help: • 𝗔𝗰𝗰𝗲𝗹𝗲𝗿𝗮𝘁𝗲 𝘁𝗶𝗺𝗲𝗹𝗶𝗻𝗲𝘀 𝗯𝘆 𝘂𝗽 𝘁𝗼 𝟵𝟬% • 𝗠𝗲𝗲𝘁 𝗸𝗲𝘆 𝗺𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲𝘀 𝗳𝗮𝘀𝘁𝗲𝗿 • 𝗥𝗲𝗱𝘂𝗰𝗲 𝗰𝗼𝘀𝘁𝘀 𝘄𝗵𝗶𝗹𝗲 𝗽𝗿𝗲𝘀𝗲𝗿𝘃𝗶𝗻𝗴 𝗜𝗣 𝗹𝗶𝗳𝗲 📍 𝗝𝗼𝗶𝗻 𝘂𝘀 𝗮𝘁 𝗕𝗼𝗼𝘁𝗵 𝟭𝟬𝟰𝟭 – Let’s discuss how ClinSense™ can support your digital health innovations! 💡 Ready to connect? Drop by and meet our team in Orlando, February 3-6. Maximilian Regenold John Varaklis #DigitalHealth, #RegulatoryCompliance, #ClinicalTrials, #HealthTech, #AIinHealthcare

We’re thrilled to introduce Nutra Compliance, our newly rebranded service born from the integration of regenold GmbH (Germany) and JensonR+ Limited (UK). Over the last 12 months, this exciting collaboration has unified our Foods, Cosmetics, and General Products Regulatory Consulting experts into a single, expanded team operating across Europe. Nutra Compliance represents the best of both worlds: the same personalized service and expert guidance you’ve come to expect, now strengthened by double the size and resources. Our specialists excel in regulatory affairs, product development, quality assurance, nutravigilance and cosmetovigilance, product notifications, cross-border challenges, global expansions, and more. We tailor our services to help our clients navigate complex regulations and bring their products to market with confidence. Along with our new name, we’re delighted to unveil our brand-new website: https://lnkd.in/ekxEtXHX. Be sure to explore the site for insights into how our enhanced expertise can support your business. We’d love for you to connect with us on LinkedIn as well where we’ll keep you updated on industry trends, compliance tips, and company news. Check out our new website today, and feel free to reach out if you have any questions or want to discuss how Nutra Compliance can help your products shine in the global market! Congratulations to the Nutra Compliance Team: Mihai Inceu, Ramona Flörchinger, Dr. Carolin Friedle, Franziska Neuhaus, Linn Voß, Janet Worrell, and Tanya Rowe #𝗖𝗼𝘀𝗺𝗲𝘁𝗶𝗰𝘀, #𝗡𝘂𝘁𝗿𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹𝘀, #𝗗𝗶𝗲𝘁𝗮𝗿𝘆𝗦𝘂𝗽𝗽𝗹𝗲𝗺𝗲𝗻𝘁𝘀, #𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲, #𝗙𝗼𝗼𝗱𝗦𝗮𝗳𝗲𝘁𝘆

𝗪𝗲’𝗿𝗲 𝗵𝗲𝗮𝗱𝗶𝗻𝗴 𝘁𝗼 𝗗𝘂𝗯𝗮𝗶! From 27–30 January 2025, regenold GmbH will be on the ground at 𝗔𝗿𝗮𝗯 𝗛𝗲𝗮𝗹𝘁𝗵 𝟮𝟬𝟮𝟱—a global hub for healthcare innovation at the 𝗗𝘂𝗯𝗮𝗶 𝗪𝗼𝗿𝗹𝗱 𝗧𝗿𝗮𝗱𝗲 𝗖𝗲𝗻𝘁𝗿𝗲. Expect lively conversations on emerging technologies, new strategies, and groundbreaking best practices that are shaping the future of healthcare. We’ll be making the rounds with regenold team mates Marcel Wöllbrink, Maximilian Regenold, and John Varaklis as well as our partners and colleagues at mdi Europa GmbH and JensonR+ Limited. We’re eager to network with industry peers, exchange fresh perspectives, and discover the next wave of medical advancements. If you’re attending, drop us a note and let’s meet up for a chat and make the most of this world-class event together! See you in Dubai! #ArabHealth, #DigitalHealth, #HealthcareInnovation, #MedicalTechnology, #MedTech

𝗔𝘂𝗳 𝗱𝗲𝗿 𝗦𝘂𝗰𝗵𝗲 𝗻𝗮𝗰𝗵 𝗲𝗶𝗻𝗲𝗺 𝗝𝗼𝗯? 𝗖𝗵𝗲𝗰𝗸! Wir verstärken das regenold Team und suchen Dich: 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 / 𝗢𝗳𝗳𝗶𝗰𝗲 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 (𝗺/𝘄/𝗱) Weitere Details zur Stelle findest du unter: https://lnkd.in/em6hTkDw Mehr Karriere Möglichkeiten findest Du hier: https://lnkd.in/eWJ6FYjJ

𝗦𝗲𝗲 𝘆𝗼𝘂 𝗮𝘁 𝘁𝗵𝗲 𝟮𝟬𝟮𝟱 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗘𝗨 𝗦𝘂𝗺𝗺𝗶𝘁! We are thrilled to announce that regenold GmbH will be attending the 𝟮𝟬𝟮𝟱 𝗖𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗣𝗿𝗼𝗱𝘂𝗰𝘁𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗘𝗨 summit, taking place on 𝟮𝟴–𝟮𝟵 𝗝𝗮𝗻𝘂𝗮𝗿𝘆 𝟮𝟬𝟮𝟱 at the 𝗥𝗮𝗱𝗶𝘀𝘀𝗼𝗻 𝗚𝗿𝗮𝗻𝗱 𝗣𝗹𝗮𝗰𝗲 𝗶𝗻 𝗕𝗿𝘂𝘀𝘀𝗲𝗹𝘀, 𝗕𝗲𝗹𝗴𝗶𝘂𝗺. We’re looking forward to participating as this extraordinary event that provides the perfect environment to exchange ideas and insights with industry leaders. If you’re planning to attend, we’d love to connect! Let us know so we can arrange to meet up. Felix Metzner We can’t wait to engage with fellow experts, share knowledge, and discover innovative approaches that drive progress in the world of Combination Products. See you in Brussels! #CombinationProducts, #MedicalDevices, #MedTech, #DrugDelivery, #Biopharmaceuticals

𝗔𝘂𝗳 𝗱𝗲𝗿 𝗦𝘂𝗰𝗵𝗲 𝗻𝗮𝗰𝗵 𝗲𝗶𝗻𝗲𝗺 𝗝𝗼𝗯? 𝗖𝗵𝗲𝗰𝗸! Wir verstärken das regenold Team und suchen Dich als 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 𝗠𝗮𝗻𝗮𝗴𝗲𝗿 (m/w/d) in Teilzeit: Weitere Details zur Stelle findest du unter: https://lnkd.in/eMxzehkr Mehr Karriere Möglichkeiten findest Du hier: https://lnkd.in/eWJ6FYjJ

Congratulations to the DTx Consulting Alliance, dtXca for their continued success in supporting and advancing digital health solutions! 🎉 At regenold GmbH, we are incredibly proud to be a member of this forward-thinking group of digital pioneers and we are excited to collaborate with all the dedicated members as we work together to shape the future of healthcare through innovative digital solutions. A warm and hearty welcome to Bornholdt Lee GmbH! Here's to many more milestones ahead! 🚀 #DigitalHealth, #DTx, #PharmaInnovation, #DiGA, #HealthcareInnovation