Updates

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

We have assisted a diagnostics company with its companion diagnostics strategy, including the regulatory implications of combining diagnostic and therapeutic products.

We have advised an IVD manufacturer on a bringing companion diagnostic to market with respect to a patient support program.

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

We have assisted multiple manufacturers with the transition of their legacy IVD Directive products to the IVDR framework.

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

Axon assisted a Dutch oncology company, developing small molecule inhibitors for the precision treatment of cancer, with the structuring and completion of its Series A financing round. We advised on the drafting of all corporate resolutions, conditions precedent and related filtering and closing matters.

We have advised pharmacies on the regulatory aspects of pharmaceutical compounding.

Axon assisted the shareholders of a Dutch medtech company, specialising in epilepsy detection devices, in the sale of the company to a Scandinavian healthcare technology group. We advised on the transaction structure, share purchase documentation and related matters.

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.