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Zühlke and Confinis launch 'Beyond' to power regulatory compliance in the age of AI
This partnership brings together two decades of regulatory consulting experience with Zühlke’s deep track record in artificial intelligence, data engineering, and software innovation. Initially focused on the MedTech sector, the offering is designed to scale across biotech and pharma, supporting companies of all sizes, from startups building regulatory functions from scratch to established players looking to enhance compliance and decision-making.
“The future of engineering consulting is service-as-software, where intelligent systems and expert human guidance work hand in hand. Together with Confinis, we’re unlocking the next level of regulatory compliance with agentic AI workflows that are practical, scalable, and built for real-world impact.”
With Beyond, clients can automate and streamline tasks such as technology file verification, internal audits, post-market surveillance, and other critical compliance activities. The solution uses Zühlke’s proprietary ZenAI platform – part of a broader suite of Zühlke-developed AI capabilities – and is tailored to each client’s data landscape and business needs.
“We believe AI is a game-changer for regulatory consulting, but only when it’s grounded in deep domain expertise. By combining our regulatory know-how with Zühlke’s AI capabilities, we’re delivering solutions that are not just smart, but truly transformative for the industry.”
The two companies will showcase the new offering at several joint events this autumn:
- A live demo at the MedTech & Pharma Platform in Basel on September 16
- A keynote by Christian Moser at the National Regulatory Conference in Berne on October 15
- A MedTech roundtable at Zühlke’s office in Schlieren, with Confinis as guest, on October 22 (tbc.)
Commercialisation of the Beyond offering is planned to begin in October 2025, with demo materials and a landing page currently in development.
About Confinis
Confinis is a regulatory consultancy with over 20 years of experience in MedTech, Pharma, and Biotech. With offices in Switzerland, the US, UK and Germany, they support clients across the full product lifecycle – from strategy and regulatory affairs to quality management and clinical operations.
About Zühlke
Zühlke is a global partner for transformation and innovation with deep roots in engineering. Clients rely on the company’s expertise to plan and develop their business of tomorrow. In doing so, Zühlke helps them work more efficiently today while preparing for the challenges of tomorrow.
Founded in Switzerland in 1968, Zühlke remains partner-owned, with offices across Europe and Asia. Its venture capital service, Zühlke Ventures, provides funding for startups in the HealthTech sector.