Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.
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Axon assisted a cosmetics company facing enforcement by the Dutch Food and Consumer Product Authority NVWA re. the sample service it operated. Axon advised the company on the applicable CPNP notification and labelling requirements, based on which the company could ensure compliance.
Our team has trained several multinationals on the implications of the Battery Regulation and the Packaging & Packaging Waste regulation, and regularly advises on these topics.
We have advised a large pharmaceutical company on the conduct of combined studies in collaboration with IVD manufacturers.
We have advised a start-up on the legal limitations and requirements related to the transport of dangerous substances.
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.