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

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Blogs Testimonial
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Agriculture Biotech Chemicals Cosmetics Diagnostics Digital Health Food and Feed Healthcare Medical Devices Pharmaceuticals
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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 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 advised manufacturers, distributors and authorised representatives on all aspects of the IVDR, including assisting a diagnostics manufacturer with the classification and conformity assessment of its in vitro diagnostic medical devices under the new IVDR framework.

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

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

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

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 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.