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

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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.

Chemicals Environmental and Sustainability Regulatory Compliance and Enforcement Testimonial

Our team has trained several multinationals on the implications of the Battery Regulation and the Packaging & Packaging Waste regulation, and regularly advises on these topics.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have guided several clients through notified body interactions and discussions with competent authorities on product classification.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.

Diagnostics Pharmaceuticals Regulatory Compliance and Enforcement Testimonial

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.

Diagnostics Regulatory Compliance and Enforcement Testimonial

Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.

Diagnostics Regulatory Compliance and Enforcement Testimonial

We have supported an IVD manufacturer in the design and conduct of performance studies. We regularly advise clients on post-market performance follow-up (PMPF) obligations.