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Explore our latest insights, regulatory updates, and strategic reports for the life sciences sector.

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Intellectual Property and Licensing Spin-out and Starter Advisory Blog

Modernised Dutch Patents Act: From Rubber Stamp to Examination

A proposal for the modernisation of the Dutch Patent Act (Rijksoctrooiwet 1995) is currently under consideration by the Parliament. In this article, we briefly outline the most important implications for the Dutch life sciences sector and, in particular, for university spinouts.

Agriculture Biotech Food and Feed Regulatory Compliance and Enforcement Spin-out and Starter Advisory Testimonial

As a partner of StartLife, Axon assisted a feed company with the regulatory qualification of its technology. Our reasoned opinion serves as a key document for the company’s funding activities.

Diagnostics Food and Feed Commercial Contracts Intellectual Property and Licensing Spin-out and Starter Advisory Testimonial

Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.

Medical Devices Regulatory Compliance and Enforcement Spin-out and Starter Advisory Testimonial

We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.

Data Protection, (Cyber)security and AI Testimonial

We set up procedures for multiple clients continues transfers of personal data beyond the EU, including to countries without an adequate data protection regime, for various purposes.

Medical Devices Data Protection, (Cyber)security and AI Due Diligence Regulatory Compliance and Enforcement Testimonial

We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.

Medical Devices Data Protection, (Cyber)security and AI Testimonial

On behalf of a medical device company, we reported a personal data breach to the supervisory authority and have advised on internal communication.

Healthcare Data Protection, (Cyber)security and AI Testimonial

We have assisted a client in setting up a multinational data strategy, including advice on anonymisation of personal data and interaction product regulations and the upcoming high-risk regime under the European Health Data Space Act (EHDS Act) to help them continue innovating without endangering company confidential developments.

Data Protection, (Cyber)security and AI Testimonial

For a client conducting a multinational clinical investigation, we have drafted informed consent notices that allow for long term use of clinical research data beyond the confines of the study.

Medical Devices Data Protection, (Cyber)security and AI Testimonial

We have trained the entire regulatory team of a medical device company on understanding GDPR compliance in a clinical research setting.