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

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25 results

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

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.

Biotech Diagnostics Corporate, Governance and Boardroom Counselling Due Diligence Financing and M&A Testimonial

Axon acted on behalf of an investor in connection with their investment in a clinical-stage biotech company developing first-in-class therapeutics and diagnostics for fibrosis. We conducted legal due diligence on the target company and reviewed the transaction documentation on behalf of the investors.

Diagnostics Healthcare Corporate, Governance and Boardroom Counselling Financing and M&A Testimonial

Axon assisted a Dutch IVD company in securing a EUR 24M equity financing round, advising on the transaction structure, investment documentation and related matters.