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).

Axon assisted a French VC company investing in a food tech start-up. We reviewed the target’s regulatory strategy under the EU novel foods framework, assessed its feasibility and outlined potential risks and how to mitigate these.

What distinguishes our lawyers is the ability to see the whole regulatory picture. We have assisted multiple clients, ranging from CROs to pharma start-ups to medical device manufacturers, in setting up GDPR compliance processes and agreements that allow for seamless interaction with other legal frameworks such as MDR and IVDR.

We have assisted a client in setting up a multinational data strategy, including advice on anonymisation of personal data and interaction product regulations and the upcoming high-risk regime under the European Health Data Space Act (EHDS Act) to help them continue innovating without endangering company confidential developments.

We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.

We have assisted several clients in challenging tender decisions by Dutch hospitals.

We have advised a client on an inspection by the Dutch Healthcare Inspectorate (IGJ).

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 pharmaceutical companies with legal advice across the full product lifecycle, from early-stage development through to market authorisation and post-marketing compliance.