Lifesciences
31/03/2025 – London UK – Generis, creator of leading life sciences platform CARA, and Regenold GmbH, a specialist in regulatory affairs and quality management for medical devices, have partnered to revolutionise the way medical device companies manage Regulatory Information and Quality. This strategic partnership will enable medical device organisations to streamline compliance, improve efficiency, and accelerate time-to-market through a seamlessly integrated, AI-enabled solution.
‘At regenold, we are dedicated to support medical device companies not only with deep regulatory expertise but also with the right tools to navigate the ever-evolving regulatory landscape. This partnership allows us to combine our regulatory and industry know-how, as well as our extensive experience with notified bodies, with the powerful, AI-enhanced platform capabilities of Generis’ CARA Platform.
We are convinced that this partnership marks a major milestone in supporting medical device manufacturers maintain a competitive edge while ensuring the safe and timely delivery of healthcare solutions.’ highlighted by Dr. Katrin Wiemann, Managing Director of regenold.
Medical device companies must manage complex submissions and compliance requirements while maintaining data integrity and accessibility to enable global market access and distribution of their entire portfolio.
As a Build Partner, regenold can leverage the functionality and flexibility of the CARA Platform to deliver a tailored solution designed specifically for the challenges faced by medical device manufacturers.
‘We’re delighted to welcome our latest build partner – regenold are uniquely positioned to leverage CARA to power the first R&D platform that is truly developed and focused on medical devices.’ commented Max Kelleher, CEO of Generis.
regenold brings decades of experience supporting medical device companies with regulatory strategy, submissions, and quality system implementation. Through this partnership, medical device companies can leverage regenold’s expertise to optimise their processes, ensuring that they stay competitive and deliver products vital to public health.
The CARA Life Sciences Platform built based on industry standards and regulatory guidelines, allows companies to navigate complex processes across the R&D landscape including RIM, QMS, Safety and PV, eTMF, CTMS and more. The data is stored a single, structured information lake, streamlining accessibility, traceability, and reuse of that data in other processes across the enterprise.
Key Benefits for Medical Device Companies:
- End-to-End R&D Data and Document Management – A single platform to manage regulatory submissions, compliance documentation, and quality processes, reducing manual effort and improving data integrity.
- Faster Market Access – Streamlined processes ensure that medical devices reach the market faster while maintaining compliance with global regulatory standards.
- Enhanced Collaboration & Efficiency – A digital-first approach eliminates silos, allowing teams to work together in real time with additional GenAI tools to boost
- Ensured Compliance – Protect your data and content with granular security, role-based access, and audit trails for every action, keeping you compliant at all stages.
Generis and Regenold share a commitment to innovation and excellence in the medical device industry, harnessing new tools such as AI for better customer experience. Through this collaboration, they aim to empower organisations with the tools and expertise needed to streamline regulatory processes and drive business success.
About Generis
Generis is a UK-headquartered developer of world-class AI enabled data, content and business process management for regulated industries globally. 60% of the top 20 life sciences companies rely on Generis’ flagship CARA™ Life Sciences Platform, including AbbVie, UCB, Biogen, Reckitt, Bristol Myers Squibb, Bayer, Pfizer, and Merck KGaA. Today Generis serves more than 750,000 users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. More at generiscorp.com / caralifesciences.com
About Regenold GmbH
Regenold GmbH specializes in development, regulatory, and market access services, supporting clients worldwide in bringing their products to market. Since 1994, the company has helped clients navigate complex regulatory landscapes and secure marketing authorizations across global markets.
With its divisions Nextec Medical and CE Plus, a division of regenold GmbH, focuses on regulatory affairs for Medical Devices and In Vitro Diagnostics, offering expertise on a global scale.
Regenold provide not only tailored strategies but also hands-on support, covering all regulatory and quality aspects throughout the entire product lifecycle – from development to post-market surveillance.
More at https://ceplus.eu/.
