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

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Sectors (2)

Agriculture Biotech Chemicals Cosmetics Diagnostics Digital Health Food and Feed Healthcare Medical Devices Pharmaceuticals

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Advertising and Claims Commercial Contracts Corporate, Governance and Boardroom Counselling Data Protection, (Cyber)security and AI Due Diligence Environmental and Sustainability Financing and M&A Intellectual Property and Licensing Litigation Regulatory Compliance and Enforcement Spin-out and Starter Advisory Subsidies and Grants

Diagnostics Digital Health Clear all

19 results

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Diagnostics Regulatory Compliance and Enforcement Testimonial

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

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.