Updates

Axon regularly acts as a sub-contractor for leading international firms to assist in regulatory due diligence in our fields of expertise: pharma, medical technology and food.

We have advised a company on defending itself against an enforcement action brought by the Netherlands Food and Consumer Product Safety Authority (NVWA).

We have advised a Dutch packaging manufacturer on the use of colours, inks and substances in food packaging and have prepared a fact sheet on environmental claims for a client focussed on sustainable packaging.

We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.

We have advised several clients on the conduct and defence of complaints made to the Dutch Advertising Committee regarding claims about products such as foods, pharmaceuticals and medical devices across Dutch media.

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.