We have guided several clients through notified body interactions and discussions with competent authorities on product classification.
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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.
We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.
Our team has advised an IVD-manufacturer on use of the inhouse-exemption under the IVDR.
We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.
We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.
We have advised a laboratory on the regulatory status of laboratory developed tests (LDTs) under the IVDR.
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.
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.
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.