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

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21 results

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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 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.

Biotech Corporate, Governance and Boardroom Counselling Intellectual Property and Licensing Spin-out and Starter Advisory Testimonial

Axon regularly advises spin-outs from academic institutions on a wide range of topics. We make sure that the spin-out’s license agreement includes commercially and legally viable terms and is attractive to investors. In addition, we advise on the corporate structure of the spin-out, balancing the interest of the founders, the academic institution and all other stakeholders.

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.

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

Axon assisted a Dutch cultivated materials company in securing a EUR 22M Series A financing round. We advised on the transaction structure, investment documentation and related matters.

Biotech Pharmaceuticals Commercial Contracts Intellectual Property and Licensing Testimonial

Axon advised a stock-listed biopharmaceutical company on antibody licensing and technology transfer agreements with two major US-based pharmaceutical companies. The deals involved the grant of commercial rights to the licensor's proprietary antibody platform technology.